Trial Outcomes & Findings for Ticagrelor China Pharmacokinetic/Pharmacodynamic Study (NCT NCT02064985)
NCT ID: NCT02064985
Last Updated: 2016-05-11
Results Overview
The Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily). Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA).
COMPLETED
PHASE4
61 participants
Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1
2016-05-11
Participant Flow
The first patient was recruited on February 27th 2014 and the last patient's informed consent was obtained on Oct 24th 2014.
22 participants did not meet includion/exclusion criteria. 2 participants withdrawed from study due to subject decision.1 participant withdrawed due to other reason. 36 participants were randomized and received study medication.
Participant milestones
| Measure |
Ticagrelor 45mg
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ticagrelor China Pharmacokinetic/Pharmacodynamic Study
Baseline characteristics by cohort
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Age, Customized
< 65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1Population: All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).
The Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily). Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA).
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
IPA on Day 1
1 hour after dose intake
|
57.20 % IPA
Standard Deviation 26.563
|
50.97 % IPA
Standard Deviation 32.747
|
61.64 % IPA
Standard Deviation 31.244
|
|
IPA on Day 1
0.5 hour after dose intake
|
27.09 % IPA
Standard Deviation 25.956
|
25.87 % IPA
Standard Deviation 27.036
|
33.34 % IPA
Standard Deviation 31.238
|
|
IPA on Day 1
2 hours after dose intake
|
82.24 % IPA
Standard Deviation 21.160
|
84.10 % IPA
Standard Deviation 17.645
|
86.11 % IPA
Standard Deviation 22.213
|
|
IPA on Day 1
3 hours after dose intake
|
88.44 % IPA
Standard Deviation 11.786
|
90.18 % IPA
Standard Deviation 9.232
|
96.24 % IPA
Standard Deviation 6.396
|
|
IPA on Day 1
6 hours after dose intake
|
85.02 % IPA
Standard Deviation 8.965
|
94.32 % IPA
Standard Deviation 6.243
|
94.02 % IPA
Standard Deviation 6.190
|
|
IPA on Day 1
12 hours after dose intake
|
71.25 % IPA
Standard Deviation 16.518
|
85.70 % IPA
Standard Deviation 15.237
|
90.70 % IPA
Standard Deviation 8.117
|
|
IPA on Day 1
24 hours after dose intake
|
44.11 % IPA
Standard Deviation 34.165
|
49.38 % IPA
Standard Deviation 25.153
|
66.48 % IPA
Standard Deviation 21.200
|
|
IPA on Day 1
36 hours after dose intake
|
40.09 % IPA
Standard Deviation 28.211
|
46.23 % IPA
Standard Deviation 17.352
|
55.64 % IPA
Standard Deviation 29.446
|
|
IPA on Day 1
48 hours after dose intake
|
23.56 % IPA
Standard Deviation 22.956
|
27.25 % IPA
Standard Deviation 17.993
|
43.04 % IPA
Standard Deviation 25.178
|
PRIMARY outcome
Timeframe: Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7Population: All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).
The inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily). Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA).
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
IPA on Day 7
0 hour after dose intake
|
79.69 % IPA
Standard Deviation 20.547
|
89.26 % IPA
Standard Deviation 7.857
|
95.10 % IPA
Standard Deviation 6.910
|
|
IPA on Day 7
0.5 hour after dose intake
|
84.70 % IPA
Standard Deviation 15.998
|
89.96 % IPA
Standard Deviation 7.985
|
96.90 % IPA
Standard Deviation 3.602
|
|
IPA on Day 7
1 hour after dose intake
|
88.82 % IPA
Standard Deviation 15.639
|
93.28 % IPA
Standard Deviation 7.589
|
96.47 % IPA
Standard Deviation 4.184
|
|
IPA on Day 7
2 hours after dose intake
|
88.30 % IPA
Standard Deviation 17.325
|
94.62 % IPA
Standard Deviation 3.787
|
98.29 % IPA
Standard Deviation 3.526
|
|
IPA on Day 7
3 hours after dose intake
|
91.00 % IPA
Standard Deviation 13.212
|
97.01 % IPA
Standard Deviation 2.258
|
98.86 % IPA
Standard Deviation 2.664
|
|
IPA on Day 7
6 hours after dose intake
|
91.13 % IPA
Standard Deviation 14.344
|
92.94 % IPA
Standard Deviation 17.847
|
98.87 % IPA
Standard Deviation 2.598
|
|
IPA on Day 7
12 hours after dose intake
|
86.55 % IPA
Standard Deviation 16.918
|
92.01 % IPA
Standard Deviation 7.316
|
96.81 % IPA
Standard Deviation 4.219
|
SECONDARY outcome
Timeframe: Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1Population: All randomized patients who received at least one dose of investigational product with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (e.g., non-compliance with study drug) will be included in the PD analysis set.
Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Percent Change From Baseline in PRU on Day 1
0.5 hour after dose intake
|
-19.20 % change from baseline
Standard Deviation 13.712
|
-13.76 % change from baseline
Standard Deviation 22.786
|
-19.59 % change from baseline
Standard Deviation 23.880
|
|
Percent Change From Baseline in PRU on Day 1
1 hour after dose intake
|
-60.00 % change from baseline
Standard Deviation 27.295
|
-35.25 % change from baseline
Standard Deviation 28.795
|
-67.70 % change from baseline
Standard Deviation 30.613
|
|
Percent Change From Baseline in PRU on Day 1
2 hours after dose intake
|
-72.60 % change from baseline
Standard Deviation 16.492
|
-61.23 % change from baseline
Standard Deviation 23.304
|
-78.85 % change from baseline
Standard Deviation 18.775
|
|
Percent Change From Baseline in PRU on Day 1
3 hours after dose intake
|
-71.58 % change from baseline
Standard Deviation 22.220
|
-75.42 % change from baseline
Standard Deviation 15.315
|
-87.97 % change from baseline
Standard Deviation 11.134
|
|
Percent Change From Baseline in PRU on Day 1
6 hours after dose intake
|
-60.27 % change from baseline
Standard Deviation 25.208
|
-67.98 % change from baseline
Standard Deviation 16.709
|
-81.08 % change from baseline
Standard Deviation 11.024
|
|
Percent Change From Baseline in PRU on Day 1
12 hours after dose intake
|
-41.93 % change from baseline
Standard Deviation 23.584
|
-47.15 % change from baseline
Standard Deviation 20.310
|
-73.47 % change from baseline
Standard Deviation 13.705
|
|
Percent Change From Baseline in PRU on Day 1
24 hours after dose intake
|
-35.94 % change from baseline
Standard Deviation 20.706
|
-28.34 % change from baseline
Standard Deviation 19.865
|
-54.61 % change from baseline
Standard Deviation 19.553
|
|
Percent Change From Baseline in PRU on Day 1
36 hours after dose intake
|
-9.57 % change from baseline
Standard Deviation 17.655
|
-1.91 % change from baseline
Standard Deviation 18.120
|
-22.59 % change from baseline
Standard Deviation 24.694
|
|
Percent Change From Baseline in PRU on Day 1
48hours after dose intake
|
-15.19 % change from baseline
Standard Deviation 23.331
|
-0.57 % change from baseline
Standard Deviation 13.070
|
-16.38 % change from baseline
Standard Deviation 18.164
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Ticagrelor on Day 7(1)
|
616.0 ng/mL
Geometric Coefficient of Variation 37.09
|
689.4 ng/mL
Geometric Coefficient of Variation 33.64
|
1273 ng/mL
Geometric Coefficient of Variation 43.00
|
SECONDARY outcome
Timeframe: Baseline, Day 1 to Day 7 and 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (seated blood pressure \[BP\])
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Vital Signs Over Time---Blood Pressure
Diastolic Blood Pressure-Day 6
|
79.8 mmHg
Standard Deviation 8.7
|
77.4 mmHg
Standard Deviation 4.8
|
73.9 mmHg
Standard Deviation 11.5
|
|
Safety---Vital Signs Over Time---Blood Pressure
Systolic Blood Pressure-Day 2
|
130.3 mmHg
Standard Deviation 15.0
|
131.4 mmHg
Standard Deviation 20.0
|
123.1 mmHg
Standard Deviation 14.2
|
|
Safety---Vital Signs Over Time---Blood Pressure
Systolic Blood Pressure-Day 3
|
128.3 mmHg
Standard Deviation 11.0
|
130.1 mmHg
Standard Deviation 18.8
|
123.8 mmHg
Standard Deviation 9.5
|
|
Safety---Vital Signs Over Time---Blood Pressure
Systolic Blood Pressure-Day 5
|
129.4 mmHg
Standard Deviation 11.0
|
131.3 mmHg
Standard Deviation 18.6
|
125.1 mmHg
Standard Deviation 11.0
|
|
Safety---Vital Signs Over Time---Blood Pressure
Diastolic Blood Pressure- Baseline
|
84.6 mmHg
Standard Deviation 7.6
|
77.1 mmHg
Standard Deviation 9.7
|
74.8 mmHg
Standard Deviation 15.5
|
|
Safety---Vital Signs Over Time---Blood Pressure
Diastolic Blood Pressure- Day 1
|
85.3 mmHg
Standard Deviation 9.0
|
78.2 mmHg
Standard Deviation 9.6
|
74.6 mmHg
Standard Deviation 11.3
|
|
Safety---Vital Signs Over Time---Blood Pressure
Diastolic Blood Pressure-Day 2
|
82.3 mmHg
Standard Deviation 9.3
|
74.8 mmHg
Standard Deviation 7.5
|
74.2 mmHg
Standard Deviation 11.3
|
|
Safety---Vital Signs Over Time---Blood Pressure
Diastolic Blood Pressure-Day 3
|
79.2 mmHg
Standard Deviation 11.0
|
75.2 mmHg
Standard Deviation 7.5
|
74.3 mmHg
Standard Deviation 11.5
|
|
Safety---Vital Signs Over Time---Blood Pressure
Diastolic Blood Pressure-Day 4
|
80.7 mmHg
Standard Deviation 11.4
|
78.2 mmHg
Standard Deviation 8.7
|
73.3 mmHg
Standard Deviation 11.2
|
|
Safety---Vital Signs Over Time---Blood Pressure
Diastolic Blood Pressure-Day 5
|
80.8 mmHg
Standard Deviation 10.3
|
75.2 mmHg
Standard Deviation 5.6
|
74.7 mmHg
Standard Deviation 9.5
|
|
Safety---Vital Signs Over Time---Blood Pressure
Diastolic Blood Pressure-Day 7
|
80.8 mmHg
Standard Deviation 7.7
|
75.6 mmHg
Standard Deviation 6.7
|
74.0 mmHg
Standard Deviation 11.5
|
|
Safety---Vital Signs Over Time---Blood Pressure
Diastolic Blood Pressure-2-5 days after last Dose
|
80.3 mmHg
Standard Deviation 6.8
|
74.7 mmHg
Standard Deviation 6.7
|
71.3 mmHg
Standard Deviation 9.2
|
|
Safety---Vital Signs Over Time---Blood Pressure
Systolic Blood Pressure (mmHg)-Baseline
|
134.6 mmHg
Standard Deviation 14.6
|
129.2 mmHg
Standard Deviation 11.6
|
132.1 mmHg
Standard Deviation 14.5
|
|
Safety---Vital Signs Over Time---Blood Pressure
Systolic Blood Pressure-Day 1
|
132.2 mmHg
Standard Deviation 12.0
|
135.7 mmHg
Standard Deviation 19.2
|
127.4 mmHg
Standard Deviation 11.9
|
|
Safety---Vital Signs Over Time---Blood Pressure
Systolic Blood Pressure-Day 4
|
131.3 mmHg
Standard Deviation 12.8
|
132.8 mmHg
Standard Deviation 15.3
|
126.1 mmHg
Standard Deviation 12.0
|
|
Safety---Vital Signs Over Time---Blood Pressure
Systolic Blood Pressure-Day 6
|
126.8 mmHg
Standard Deviation 14.0
|
133.5 mmHg
Standard Deviation 19.5
|
119.1 mmHg
Standard Deviation 9.2
|
|
Safety---Vital Signs Over Time---Blood Pressure
Systolic Blood Pressure-Day 7
|
128.9 mmHg
Standard Deviation 11.8
|
129.4 mmHg
Standard Deviation 22.7
|
122.1 mmHg
Standard Deviation 11.3
|
|
Safety---Vital Signs Over Time---Blood Pressure
Systolic Blood Pressure-2-5 days after last Dose
|
126.0 mmHg
Standard Deviation 16.0
|
132.3 mmHg
Standard Deviation 17.3
|
124.7 mmHg
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7Population: All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).
Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Percent Change From Baseline in PRU on Day 7
0.5 hour after dose intake
|
-77.90 % change from baseline
Standard Deviation 17.632
|
-80.07 % change from baseline
Standard Deviation 14.691
|
-89.33 % change from baseline
Standard Deviation 8.923
|
|
Percent Change From Baseline in PRU on Day 7
1 hour after dose intake
|
-79.70 % change from baseline
Standard Deviation 17.742
|
-78.40 % change from baseline
Standard Deviation 18.103
|
-94.10 % change from baseline
Standard Deviation 6.746
|
|
Percent Change From Baseline in PRU on Day 7
2 hours after dose intake
|
-82.23 % change from baseline
Standard Deviation 17.304
|
-85.00 % change from baseline
Standard Deviation 12.020
|
-88.81 % change from baseline
Standard Deviation 13.595
|
|
Percent Change From Baseline in PRU on Day 7
3 hours after dose intake
|
-79.98 % change from baseline
Standard Deviation 18.434
|
-86.96 % change from baseline
Standard Deviation 12.868
|
-92.13 % change from baseline
Standard Deviation 9.288
|
|
Percent Change From Baseline in PRU on Day 7
6 hours after dose intake
|
-76.71 % change from baseline
Standard Deviation 20.067
|
-75.07 % change from baseline
Standard Deviation 14.806
|
-91.48 % change from baseline
Standard Deviation 7.928
|
|
Percent Change From Baseline in PRU on Day 7
12 hours after dose intake
|
-63.63 % change from baseline
Standard Deviation 23.767
|
-69.03 % change from baseline
Standard Deviation 19.867
|
-88.60 % change from baseline
Standard Deviation 8.816
|
SECONDARY outcome
Timeframe: Day 1Population: All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).
The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
TIPA(Max)---Day 1
|
3.0 hour
Inter-Quartile Range 17.632 • Interval 2.5 to 6.0
|
4.5 hour
Inter-Quartile Range 14.691 • Interval 3.0 to 6.0
|
2.5 hour
Inter-Quartile Range 8.923 • Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: Day 7Population: All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).
The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
TIPA(Max)---Day 7
|
1.5 hour
Inter-Quartile Range 17.632 • Interval 1.0 to 4.5
|
6.0 hour
Inter-Quartile Range 14.691 • Interval 1.8 to 6.0
|
1.3 hour
Inter-Quartile Range 8.923 • Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1Population: All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).
The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
AUEC(Final Extent) on Day 1
|
2474.4 %*h
Standard Deviation 949.3 • Interval 1.0 to 4.5
|
2819.4 %*h
Standard Deviation 707.17 • Interval 1.8 to 6.0
|
3301.0 %*h
Standard Deviation 788.72 • Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7Population: All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).
The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
AUEC(Final Extent) on Day 7
|
1069.9 %*h
Standard Deviation 176.89 • Interval 1.0 to 4.5
|
1120.1 %*h
Standard Deviation 108.44 • Interval 1.8 to 6.0
|
1176.9 %*h
Standard Deviation 33.03 • Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Ticagrelor on Day 1(3)
tmax
|
2.00 hour
Full Range 38.02 • Interval 1.0 to 2.0
|
3.00 hour
Full Range 34.14 • Interval 1.0 to 6.0
|
2.00 hour
Full Range 37.39 • Interval 1.0 to 3.03
|
|
Pharmacokinetics Parameters of Ticagrelor on Day 1(3)
t½
|
10.07 hour
Full Range 51.42 • Interval 9.21 to 15.9
|
9.008 hour
Full Range 32.46 • Interval 7.94 to 12.5
|
9.802 hour
Full Range 53.84 • Interval 7.81 to 13.7
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t).
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Ticagrelor on Day 1(2)
AUC(0-inf)
|
3220 h*ng/mL
Geometric Coefficient of Variation 51.42
|
3633 h*ng/mL
Geometric Coefficient of Variation 32.46
|
6234 h*ng/mL
Geometric Coefficient of Variation 53.84
|
|
Pharmacokinetics Parameters of Ticagrelor on Day 1(2)
AUC(0-t)
|
3102 h*ng/mL
Geometric Coefficient of Variation 49.79
|
3533 h*ng/mL
Geometric Coefficient of Variation 31.68
|
6017 h*ng/mL
Geometric Coefficient of Variation 51.71
|
|
Pharmacokinetics Parameters of Ticagrelor on Day 1(2)
AUC(0-12h)
|
2114 h*ng/mL
Geometric Coefficient of Variation 41.97
|
2313 h*ng/mL
Geometric Coefficient of Variation 30.10
|
3983 h*ng/mL
Geometric Coefficient of Variation 41.93
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
The pharmacokinetics parameters of ticagrelor on Day 7---tmax
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Ticagrelor on Day 7(2)
|
2.00 hour
Full Range 37.09 • Interval 1.0 to 3.03
|
2.00 hour
Full Range 33.64 • Interval 1.0 to 3.0
|
2.00 hour
Full Range 43.00 • Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---Cmax
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)
|
88.28 ng/mL
Geometric Coefficient of Variation 24.58
|
77.11 ng/mL
Geometric Coefficient of Variation 53.92
|
138.6 ng/mL
Geometric Coefficient of Variation 38.37
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1: tmax and t1/2
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)
tmax
|
2.00 hour
Full Range 38.02 • Interval 2.0 to 3.0
|
3.00 hour
Full Range 34.14 • Interval 2.0 to 6.0
|
3.00 hour
Full Range 37.39 • Interval 2.0 to 3.03
|
|
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)
t½
|
13.16 hour
Full Range 51.42 • Interval 8.22 to 17.1
|
11.64 hour
Full Range 32.46 • Interval 8.0 to 20.0
|
11.29 hour
Full Range 53.84 • Interval 8.74 to 21.5
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Cmax
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)
|
143.7 ng/mL
Geometric Coefficient of Variation 26.32
|
180.1 ng/mL
Geometric Coefficient of Variation 49.83
|
300.6 ng/mL
Geometric Coefficient of Variation 31.74
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 7---tmax
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)
|
2.00 hour
Full Range 38.02 • Interval 2.0 to 6.0
|
2.00 hour
Full Range 34.14 • Interval 2.0 to 3.0
|
2.54 hour
Full Range 37.39 • Interval 2.0 to 3.1
|
SECONDARY outcome
Timeframe: Day 1Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
To determine Cmax ratio for the metabolite to that of the parent compound on Day 1
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax
|
0.2277 ratio
Standard Deviation 0.08984 • Interval 2.0 to 6.0
|
0.2146 ratio
Standard Deviation 0.06333 • Interval 2.0 to 3.0
|
0.2005 ratio
Standard Deviation 0.08334 • Interval 2.0 to 3.1
|
SECONDARY outcome
Timeframe: Day 7Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
To determine Cmax ratio of metabolite to that of the parent compound on Day 7
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax
|
0.2657 ratio
Standard Deviation 0.07820 • Interval 2.0 to 6.0
|
0.3082 ratio
Standard Deviation 0.1223 • Interval 2.0 to 3.0
|
0.2646 ratio
Standard Deviation 0.06758 • Interval 2.0 to 3.1
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Physical examination
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Physical Examination, Summary of Abnormalities
Number of patients with abnormality
|
5 Participants
7.6
|
3 Participants
9.7
|
2 Participants
15.6
|
|
Safety---Physical Examination, Summary of Abnormalities
Abdomen
|
1 Participants
9.0
|
0 Participants
9.6
|
0 Participants
11.3
|
|
Safety---Physical Examination, Summary of Abnormalities
Cardiovascular
|
0 Participants
16.0
|
0 Participants
17.3
|
0 Participants
13.9
|
|
Safety---Physical Examination, Summary of Abnormalities
General appearance
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety---Physical Examination, Summary of Abnormalities
Head and neck
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety---Physical Examination, Summary of Abnormalities
Lymph nodes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety---Physical Examination, Summary of Abnormalities
Musculoskeletal / Extremities
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety---Physical Examination, Summary of Abnormalities
Neurological
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety---Physical Examination, Summary of Abnormalities
Respiratory
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety---Physical Examination, Summary of Abnormalities
Skin
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Safety---Physical Examination, Summary of Abnormalities
Thyroid
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---hematocrit
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Hematology Laboratory Variables Over Time---hematocrit
|
0.4083 ratio
Standard Deviation 0.0365
|
0.4020 ratio
Standard Deviation 0.0465
|
0.4153 ratio
Standard Deviation 0.0369
|
SECONDARY outcome
Timeframe: All allowed concomitant medications during study treatment(up to 2-5 days after last dose), includes medications that began prior to randomization but were ongoing after randomization.Population: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Concomitant medications
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---All Allowed Concomitant Medications During Study Treatment
FOSINOPRIL
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
ENALAPRIL
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
IMIDAPRIL
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Biguanides
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Other therapeutic products
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Sulfonamides, urea derivatives
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
HYDROTALCITE
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
SIMVASTATIN
|
3 Participants
0.301
|
4 Participants
0.111
|
3 Participants
0.179
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
ANTIHYPERTENSIVES
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Aldose reductase inhibitors
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
EPALRESTAT
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Angiotensin II antagonists and diuretics
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
HYDROCHLOROTHIAZIDE+ LOSARTAN
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Antidepressants in combination with psycholeptics
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
FLUPENTIXOL+MELITRACEN
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Benzodiazepine derivatives
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
ESTAZOLAM
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Benzothiazepine derivatives
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
DILTIAZEM
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Comb/complexes aluminium, calcium, magnesium comps
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Fibrates
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
FENOFIBRATE
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Insulins and analogues for inj,intermediate-acting
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
HUMULIN 70/30
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Insulins/analogues for inj,int/long-act+fast-actin
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
INSULIN ASPART
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Nicotinic acid and derivatives
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
ACIPIMOX
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Other antifungals for topical use
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
TERBINAFINE HYDROCHLORIDE
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Other drugs for peptic ulcer and GORD
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
GEFARNATE
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Other vasodilators used in cardiac diseases
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
NICORANDIL
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Thiazolidinediones
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
ROSIGLITAZONE
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Number of patients with allowed concomitant med
|
12 Participants
3.65
|
12 Participants
1.86
|
12 Participants
1.19
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
HMG CoA reductase inhibitors
|
11 Participants
0.297
|
12 Participants
0.186
|
12 Participants
0.216
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
ATORVASTATIN
|
5 Participants
0.200
|
8 Participants
0.134
|
5 Participants
0.109
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
ROSUVASTATIN
|
3 Participants
12.25
|
0 Participants
17.89
|
4 Participants
13.48
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Beta blocking agents, selective
|
9 Participants
4.36
|
10 Participants
5.91
|
6 Participants
9.67
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
METOPROLOL
|
6 Participants
1.5
|
6 Participants
1.4
|
5 Participants
2.6
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
BISOPROLOL
|
3 Participants
0.36
|
5 Participants
0.33
|
1 Participants
0.25
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
ACE inhibitors, plain
|
5 Participants
1.6
|
2 Participants
2.0
|
6 Participants
2.5
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
PERINDOPRIL
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
BENAZEPRIL
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Dihydropyridine derivatives
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
AMLODIPINE
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
NIFEDIPINE
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Other cardiac preparations
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
TRIMETAZIDINE
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
TRIMETAZIDINE HYDROCHLORIDE
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
METFORMIN
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
METFORMIN HYDROCHLORIDE
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Organic nitrates
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
ISOSORBIDE MONONITRATE
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Angiotensin II antagonists, plain
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
IRBESARTAN
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
LOSARTAN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
TELMISARTAN
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Alpha glucosidase inhibitors
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
ACARBOSE
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Insulins and analogues for injection, fast-acting
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
INSULIN
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
INSULIN HUMAN
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Enzymes
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
KALLIDINOGENASE
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Folic acid and derivatives
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
FOLIC ACID
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Alpha and beta blocking agents
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
CARVEDILOL
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
CHINESE TRADITIONAL MEDICINE NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
HERBAL NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
Preparations inhibiting uric acid production
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
ALLOPURINOL
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
GLIMEPIRIDE
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety---All Allowed Concomitant Medications During Study Treatment
GLIQUIDONE
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Includes adverse events with an onset date on or after the date of first dose and up to and including the last study visit (up to 2-5 days after last dose).Population: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Assessment of adverse events
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Causally Related Adverse Events by System Organ Class and Preferred Term
Patients with any causally related AE
|
1 Participants
3.65
|
2 Participants
1.86
|
2 Participants
1.19
|
|
Safety---Causally Related Adverse Events by System Organ Class and Preferred Term
Respiratory, thoracic and mediastinal disorders
|
0 Participants
0.297
|
2 Participants
0.186
|
2 Participants
0.216
|
|
Safety---Causally Related Adverse Events by System Organ Class and Preferred Term
Dyspnoea
|
0 Participants
0.200
|
2 Participants
0.134
|
1 Participants
0.109
|
|
Safety---Causally Related Adverse Events by System Organ Class and Preferred Term
Haemoptysis
|
0 Participants
0.301
|
0 Participants
0.111
|
1 Participants
0.179
|
|
Safety---Causally Related Adverse Events by System Organ Class and Preferred Term
Gastrointestinal disorders
|
1 Participants
12.25
|
0 Participants
17.89
|
0 Participants
13.48
|
|
Safety---Causally Related Adverse Events by System Organ Class and Preferred Term
Diarrhoea
|
1 Participants
4.36
|
0 Participants
5.91
|
0 Participants
9.67
|
|
Safety---Causally Related Adverse Events by System Organ Class and Preferred Term
Investigations
|
1 Participants
1.5
|
0 Participants
1.4
|
0 Participants
2.6
|
|
Safety---Causally Related Adverse Events by System Organ Class and Preferred Term
Occult blood positive
|
1 Participants
0.36
|
0 Participants
0.33
|
0 Participants
0.25
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Ticagrelor on Day 1(1)
|
464.0 ng/mL
Geometric Coefficient of Variation 38.02
|
413.9 ng/mL
Geometric Coefficient of Variation 34.14
|
822.1 ng/mL
Geometric Coefficient of Variation 37.39
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
Pharmacokinetics parameters of Ticagrelor on Day 7---AUC(0-12h)
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Ticagrelor on Day 7(3)
|
3882 h*ng/mL
Geometric Coefficient of Variation 41.67
|
4351 h*ng/mL
Geometric Coefficient of Variation 36.74
|
8206 h*ng/mL
Geometric Coefficient of Variation 50.92
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Ticagrelor on Day 7(4)
|
1.837 ratio
Geometric Coefficient of Variation 23.57
|
1.882 ratio
Geometric Coefficient of Variation 20.72
|
2.060 ratio
Geometric Coefficient of Variation 22.84
|
SECONDARY outcome
Timeframe: BaselinePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Height)
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Vital Signs Over Time---Height
|
166.9 cm
Standard Deviation 7.6
|
168.8 cm
Standard Deviation 8.0
|
166.5 cm
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Weight)
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Vital Signs Over Time---Weight
|
78.7 kg
Standard Deviation 10.2
|
73.8 kg
Standard Deviation 8.5
|
73.4 kg
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Baseline, Day 1 to Day 7 and 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Pulse Rate)
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Vital Signs Over Time---Pulse Rate
Pulse Rate (BEATS/MIN)- Baseline
|
63.3 BEATS/MIN
Standard Deviation 8.6
|
60.5 BEATS/MIN
Standard Deviation 6.8
|
59.1 BEATS/MIN
Standard Deviation 5.5
|
|
Safety---Vital Signs Over Time---Pulse Rate
Pulse Rate (BEATS/MIN)- Day 1
|
64.2 BEATS/MIN
Standard Deviation 8.4
|
60.6 BEATS/MIN
Standard Deviation 6.5
|
61.3 BEATS/MIN
Standard Deviation 5.2
|
|
Safety---Vital Signs Over Time---Pulse Rate
Pulse Rate (BEATS/MIN)- Day 2
|
64.6 BEATS/MIN
Standard Deviation 10.6
|
59.8 BEATS/MIN
Standard Deviation 7.3
|
63.3 BEATS/MIN
Standard Deviation 7.2
|
|
Safety---Vital Signs Over Time---Pulse Rate
Pulse Rate (BEATS/MIN)- Day 3
|
67.3 BEATS/MIN
Standard Deviation 9.8
|
60.4 BEATS/MIN
Standard Deviation 7.1
|
61.3 BEATS/MIN
Standard Deviation 4.4
|
|
Safety---Vital Signs Over Time---Pulse Rate
Pulse Rate (BEATS/MIN)- Day 4
|
65.3 BEATS/MIN
Standard Deviation 9.2
|
61.7 BEATS/MIN
Standard Deviation 5.5
|
63.7 BEATS/MIN
Standard Deviation 6.5
|
|
Safety---Vital Signs Over Time---Pulse Rate
Pulse Rate (BEATS/MIN)- Day 5
|
66.7 BEATS/MIN
Standard Deviation 8.5
|
62.7 BEATS/MIN
Standard Deviation 7.1
|
64.2 BEATS/MIN
Standard Deviation 5.9
|
|
Safety---Vital Signs Over Time---Pulse Rate
Pulse Rate (BEATS/MIN)- Day 6
|
66.8 BEATS/MIN
Standard Deviation 8.5
|
59.9 BEATS/MIN
Standard Deviation 7.2
|
64.1 BEATS/MIN
Standard Deviation 4.4
|
|
Safety---Vital Signs Over Time---Pulse Rate
Pulse Rate (BEATS/MIN)- Day 7
|
65.4 BEATS/MIN
Standard Deviation 6.2
|
62.7 BEATS/MIN
Standard Deviation 7.8
|
62.9 BEATS/MIN
Standard Deviation 5.7
|
|
Safety---Vital Signs Over Time---Pulse Rate
Pulse Rate(BEATS/MIN)- 2 to 5 days after last dose
|
64.6 BEATS/MIN
Standard Deviation 10.9
|
61.8 BEATS/MIN
Standard Deviation 5.5
|
63.0 BEATS/MIN
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---AUC(0-12h), AUC(0-t) and AUC(0-inf)
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)
AUC(0-inf)
|
921.5 h*ng/mL
Geometric Coefficient of Variation 28.66
|
1108 h*ng/mL
Geometric Coefficient of Variation 34.83
|
1644 h*ng/mL
Geometric Coefficient of Variation 30.83
|
|
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)
AUC(0-t)
|
839.6 h*ng/mL
Geometric Coefficient of Variation 25.23
|
906.0 h*ng/mL
Geometric Coefficient of Variation 56.84
|
1534 h*ng/mL
Geometric Coefficient of Variation 28.88
|
|
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)
AUC(0-12h)
|
464.0 h*ng/mL
Geometric Coefficient of Variation 19.11
|
504.1 h*ng/mL
Geometric Coefficient of Variation 55.41
|
835.9 h*ng/mL
Geometric Coefficient of Variation 29.59
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---AUC(0-12h)
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)
|
1069 h*ng/mL
Geometric Coefficient of Variation 24.89
|
1314 h*ng/mL
Geometric Coefficient of Variation 41.02
|
2254 h*ng/mL
Geometric Coefficient of Variation 37.02
|
SECONDARY outcome
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)
|
2.304 ratio
Geometric Coefficient of Variation 24.70
|
2.606 ratio
Geometric Coefficient of Variation 28.34
|
2.697 ratio
Geometric Coefficient of Variation 27.42
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Erythrocytes
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Hematology Laboratory Variables Over Time---Erythrocytes
|
4.417 10^12/L
Standard Deviation 0.319
|
4.409 10^12/L
Standard Deviation 0.400
|
4.487 10^12/L
Standard Deviation 0.427
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Hemoglobin
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Hematology Laboratory Variables Over Time---Hemoglobin
|
137.3 g/L
Standard Deviation 11.6
|
135.4 g/L
Standard Deviation 15.2
|
138.6 g/L
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Leukocytes
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Hematology Laboratory Variables Over Time---Leukocytes
|
6.64 10^9/L
Standard Deviation 1.23
|
6.30 10^9/L
Standard Deviation 1.12
|
6.74 10^9/L
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Platelets
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Hematology Laboratory Variables Over Time---Platelets
|
205.3 10^9/L
Standard Deviation 34.5
|
186.7 10^9/L
Standard Deviation 38.5
|
227.3 10^9/L
Standard Deviation 42.4
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Glucose
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Glucose
|
7.48 mmol/L
Standard Deviation 3.65
|
7.26 mmol/L
Standard Deviation 1.86
|
5.78 mmol/L
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Alanine Aminotransferase
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase
|
0.524 ukat/L
Standard Deviation 0.297
|
0.429 ukat/L
Standard Deviation 0.186
|
0.465 ukat/L
Standard Deviation 0.216
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Aspartate Aminotransferase
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase
|
0.497 ukat/L
Standard Deviation 0.200
|
0.410 ukat/L
Standard Deviation 0.134
|
0.433 ukat/L
Standard Deviation 0.109
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Alkaline Phosphatase
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase
|
1.172 ukat/L
Standard Deviation 0.301
|
1.027 ukat/L
Standard Deviation 0.111
|
1.028 ukat/L
Standard Deviation 0.179
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Creatinine
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Creatinine
|
81.92 umol/L
Standard Deviation 12.25
|
87.50 umol/L
Standard Deviation 17.89
|
83.50 umol/L
Standard Deviation 13.48
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Total Bilirubin
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Total Bilirubin
|
13.98 umol/L
Standard Deviation 4.36
|
14.58 umol/L
Standard Deviation 5.91
|
14.81 umol/L
Standard Deviation 9.67
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Sodium
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Sodium
|
140.7 mmol/L
Standard Deviation 1.5
|
140.8 mmol/L
Standard Deviation 1.4
|
141.3 mmol/L
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Potassium
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Potassium
|
4.41 mmol/L
Standard Deviation 0.36
|
4.47 mmol/L
Standard Deviation 0.33
|
4.26 mmol/L
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Chloride
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Chloride
|
103.2 mmol/L
Standard Deviation 1.6
|
103.9 mmol/L
Standard Deviation 2.0
|
104.4 mmol/L
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Phosphate
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Phosphate
|
1.188 mmol/L
Standard Deviation 0.183
|
1.154 mmol/L
Standard Deviation 0.158
|
1.145 mmol/L
Standard Deviation 0.101
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Albumin
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Albumin
|
44.77 g/L
Standard Deviation 1.51
|
44.68 g/L
Standard Deviation 2.54
|
46.07 g/L
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Protein
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Protein
|
70.2 g/L
Standard Deviation 3.6
|
69.8 g/L
Standard Deviation 3.0
|
70.2 g/L
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Blood Urea Nitrogen
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen
|
5.875 mmol/L
Standard Deviation 1.500
|
6.392 mmol/L
Standard Deviation 1.648
|
6.108 mmol/L
Standard Deviation 1.366
|
SECONDARY outcome
Timeframe: 2 to 5 days after last dosePopulation: All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Bicarbonate
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Safety---Clinical Chemistry Variables Over Time---Bicarbonate
|
28.92 mmol/L
Standard Deviation 2.77
|
28.55 mmol/L
Standard Deviation 1.95
|
28.15 mmol/L
Standard Deviation 3.20
|
SECONDARY outcome
Timeframe: Day 1Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
To determine AUC(0-inf) ratio for the metabolite to that of the parent compound on Day 1
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)
|
0.3310 ratio
Standard Deviation 0.09838
|
0.3403 ratio
Standard Deviation 0.07381
|
0.3106 ratio
Standard Deviation 0.1283
|
SECONDARY outcome
Timeframe: Day 7Population: All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.
To determine AUC(0-12h) ratio of metabolite to that of the parent compound on Day 7.
Outcome measures
| Measure |
Ticagrelor 45mg
n=12 Participants
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 Participants
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 Participants
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)
|
0.3132 ratio
Standard Deviation 0.08899
|
0.3549 ratio
Standard Deviation 0.1351
|
0.3153 ratio
Standard Deviation 0.1120
|
Adverse Events
Ticagrelor 45mg
Ticagrelor 60mg
Ticagrelor 90mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ticagrelor 45mg
n=12 participants at risk
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
|
Ticagrelor 60mg
n=12 participants at risk
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
|
Ticagrelor 90mg
n=12 participants at risk
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
|
|---|---|---|---|
|
Infections and infestations
Tinea pedis
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
8.3%
1/12
|
8.3%
1/12
|
0.00%
0/12
|
|
Eye disorders
Vision blurred
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/12
|
8.3%
1/12
|
8.3%
1/12
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12
|
16.7%
2/12
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12
|
8.3%
1/12
|
16.7%
2/12
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Investigations
Occult blood positive
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Investigations
Electrocardiogram ST-T change
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and Principal Investigator may use the Study results (data generated at the site) and shall not publish or present any such results until the earlier of (i) the date of the first Study results publication and (ii) the end of the eighteen (18) month period following the completion, or early termination, of the Study at all participating sites.
- Publication restrictions are in place
Restriction type: OTHER