Trial Outcomes & Findings for Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease (NCT NCT01587651)
NCT ID: NCT01587651
Last Updated: 2019-01-09
Results Overview
P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. Platelet aggregation with this system is defined by PRU, with a higher PRU indicative of greater platelet aggregation, and a lower PRU indicative of inhibition.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
7 days after first randomized dose
Results posted on
2019-01-09
Participant Flow
All subjects must have been taking low dose aspirin (ASA) (75 mg to 150 mg once daily-QD) for at least 7 days prior to Screening (Visit 1), and must have continued the same regimen throughout the study.
The study consisted of a 3 to 5 day ticagrelor run-in phase followed by randomized treatment on 1 of 2 prasugrel regimens or continued ticagrelor
Participant milestones
| Measure |
Prasugrel Loading Dose
Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet
Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets
|
Prasugrel Maintenance Dose
Prasugrel 10 mg QD MD
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet
|
Ticagrelor Maintenance Dose
Ticagrelor 90 mg twice-daily (BID) MD
Ticagrelor Maintenance Dose : one 90mg film coated tablet
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
41
|
35
|
|
Overall Study
COMPLETED
|
34
|
38
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
Prasugrel Loading Dose
Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet
Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets
|
Prasugrel Maintenance Dose
Prasugrel 10 mg QD MD
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet
|
Ticagrelor Maintenance Dose
Ticagrelor 90 mg twice-daily (BID) MD
Ticagrelor Maintenance Dose : one 90mg film coated tablet
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease
Baseline characteristics by cohort
| Measure |
Prasugrel Loading Dose
n=34 Participants
Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet
Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets
|
Prasugrel Maintenance Dose
n=41 Participants
Prasugrel 10 mg QD MD
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet
|
Ticagrelor Maintenance Dose
n=35 Participants
Ticagrelor 90 mg twice-daily (BID) MD
Ticagrelor Maintenance Dose : one 90mg film coated tablet
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 9.69 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 8.84 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 6.87 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 8.62 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
36 participants
n=7 Participants
|
32 participants
n=5 Participants
|
98 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
weight
|
97.0 kg
STANDARD_DEVIATION 17.70 • n=5 Participants
|
95.4 kg
STANDARD_DEVIATION 18.85 • n=7 Participants
|
89.4 kg
STANDARD_DEVIATION 19.35 • n=5 Participants
|
94.0 kg
STANDARD_DEVIATION 18.77 • n=4 Participants
|
|
height
|
171.2 cm
STANDARD_DEVIATION 8.74 • n=5 Participants
|
171.9 cm
STANDARD_DEVIATION 10.15 • n=7 Participants
|
174.3 cm
STANDARD_DEVIATION 9.14 • n=5 Participants
|
172.4 cm
STANDARD_DEVIATION 9.41 • n=4 Participants
|
|
body mass index
|
33.2 kg/m^2
STANDARD_DEVIATION 5.88 • n=5 Participants
|
32.3 kg/m^2
STANDARD_DEVIATION 5.92 • n=7 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 4.82 • n=5 Participants
|
31.6 kg/m^2
STANDARD_DEVIATION 5.77 • n=4 Participants
|
|
diabetes mellitus history
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
5 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
hypertension history
|
26 participants
n=5 Participants
|
29 participants
n=7 Participants
|
24 participants
n=5 Participants
|
79 participants
n=4 Participants
|
|
hyperlipidemia history
|
32 participants
n=5 Participants
|
35 participants
n=7 Participants
|
31 participants
n=5 Participants
|
98 participants
n=4 Participants
|
|
peripheral artery disease history
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
body mass index category
< 30 kg/m^2
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
24 participants
n=5 Participants
|
53 participants
n=4 Participants
|
|
body mass index category
>= 30 kg/m^2
|
21 participants
n=5 Participants
|
24 participants
n=7 Participants
|
11 participants
n=5 Participants
|
56 participants
n=4 Participants
|
|
body mass index category
Unknown
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 days after first randomized dosePopulation: Primary Population includes all subjects who received at least 1 dose of randomized study drug and have valid PRU data at both randomization visit pre-dosing and end-of-treatment visit. A subject is considered to have valid PRU data for primary PD analyses if he/she does not have certain protocol deviations listed in Statistical Analysis Plan.
P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. Platelet aggregation with this system is defined by PRU, with a higher PRU indicative of greater platelet aggregation, and a lower PRU indicative of inhibition.
Outcome measures
| Measure |
Prasugrel Combined Groups
n=65 Participants
combined Prasugrel loading dose and Prasugrel maintenance dose
|
Ticagrelor
n=33 Participants
|
Prasugrel Loading Dose
prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
|
Prasugrel Maintenance Dose
prasugrel 10 mg QD for 7 days
|
|---|---|---|---|---|
|
P2Y12 Reaction Units
|
95.0 PRU (P2Y12 Reaction Units)
Standard Error 6.18
|
49.0 PRU (P2Y12 Reaction Units)
Standard Error 8.68
|
—
|
—
|
SECONDARY outcome
Timeframe: 2, 4, 24, 48 hours after first randomized dosePopulation: Primary Population
P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay measured at 2, 4, 24, 48 hours after first randomized study treatment
Outcome measures
| Measure |
Prasugrel Combined Groups
n=65 Participants
combined Prasugrel loading dose and Prasugrel maintenance dose
|
Ticagrelor
n=33 Participants
|
Prasugrel Loading Dose
n=31 Participants
prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
|
Prasugrel Maintenance Dose
n=34 Participants
prasugrel 10 mg QD for 7 days
|
|---|---|---|---|---|
|
P2Y12 Reaction Units
2 hours
|
33.7 PRU
Standard Error 3.18
|
28.9 PRU
Standard Error 4.24
|
22.1 PRU
Standard Error 4.22
|
44.8 PRU
Standard Error 4.15
|
|
P2Y12 Reaction Units
4 hours
|
41.1 PRU
Standard Error 3.67
|
29.3 PRU
Standard Error 4.54
|
24.1 PRU
Standard Error 4.69
|
57.0 PRU
Standard Error 4.53
|
|
P2Y12 Reaction Units
24 hours
|
126.8 PRU
Standard Error 7.57
|
47.6 PRU
Standard Error 8.71
|
81.6 PRU
Standard Error 8.86
|
167.8 PRU
Standard Error 8.44
|
|
P2Y12 Reaction Units
48 hours
|
159.3 PRU
Standard Error 7.68
|
38.6 PRU
Standard Error 9.07
|
118.3 PRU
Standard Error 9.22
|
199.0 PRU
Standard Error 9.07
|
SECONDARY outcome
Timeframe: 2, 4, 24, 48 hours, 7 days after first randomized dosePopulation: Primary Population
Platelet Reactivity Index (PRI) by the Vasodilator-Stimulated Phosphoprotein(VASP) assay 2, 4, 24, 48 hours and 7 days after first randomized study treatment. The VASP assay is an indirect, but relatively specific measure of inhibition of P2Y12-induced platelet activation. The assay quantifies the level of phosphorylation of the intracellular protein VASP, which undergoes phosphorylation when platelet P2Y12 receptors are blocked. The level of VASP phosphorylation, expressed as the PRI, represents the percentage inhibition relative to an assay baseline/maximal P2Y12-independent platelet aggregation.
Outcome measures
| Measure |
Prasugrel Combined Groups
n=65 Participants
combined Prasugrel loading dose and Prasugrel maintenance dose
|
Ticagrelor
n=33 Participants
|
Prasugrel Loading Dose
n=31 Participants
prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
|
Prasugrel Maintenance Dose
n=34 Participants
prasugrel 10 mg QD for 7 days
|
|---|---|---|---|---|
|
Platelet Reactivity Index
2 hours post-dose
|
18.2 percentage PRI
Standard Error 1.37
|
13.2 percentage PRI
Standard Error 1.85
|
15.8 percentage PRI
Standard Error 1.94
|
20.4 percentage PRI
Standard Error 1.87
|
|
Platelet Reactivity Index
4 hours post-dose
|
16.3 percentage PRI
Standard Error 1.58
|
14.3 percentage PRI
Standard Error 2.06
|
11.4 percentage PRI
Standard Error 2.16
|
20.9 percentage PRI
Standard Error 2.08
|
|
Platelet Reactivity Index
24 hours post-dose
|
34.3 percentage PRI
Standard Error 2.24
|
19.1 percentage PRI
Standard Error 2.71
|
24.2 percentage PRI
Standard Error 2.85
|
43.7 percentage PRI
Standard Error 2.74
|
|
Platelet Reactivity Index
48 hours post-dose
|
48.1 percentage PRI
Standard Error 2.58
|
18.7 percentage PRI
Standard Error 3.20
|
38.0 percentage PRI
Standard Error 3.37
|
57.7 percentage PRI
Standard Error 3.30
|
|
Platelet Reactivity Index
7 days post-dose
|
33.5 percentage PRI
Standard Error 2.64
|
19.8 percentage PRI
Standard Error 3.58
|
38.8 percentage PRI
Standard Error 3.87
|
29.1 percentage PRI
Standard Error 3.50
|
SECONDARY outcome
Timeframe: 2, 4, 24, 48 hours, 7 days after first randomized dosePopulation: Primary population
PRU VerifyNow P2Y12 assay device-reported percent inhibition 2, 4, 24, and 48 hours, and 7 days after first randomized study treatment VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. The percent inhibition reported by VerifyNow device represents the percentage inhibition relative to maximal P2Y12-independent platelet aggregation achieved with the same sample in the presence of the iso-thrombin receptor activating peptide.
Outcome measures
| Measure |
Prasugrel Combined Groups
n=65 Participants
combined Prasugrel loading dose and Prasugrel maintenance dose
|
Ticagrelor
n=33 Participants
|
Prasugrel Loading Dose
n=31 Participants
prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
|
Prasugrel Maintenance Dose
n=34 Participants
prasugrel 10 mg QD for 7 days
|
|---|---|---|---|---|
|
PRU Percent Inhibition (Device-reported)
2 hours post-dose
|
87.8 percent inhibition
Standard Error 1.13
|
89.2 percent inhibition
Standard Error 1.53
|
91.4 percent inhibition
Standard Error 1.53
|
84.3 percent inhibition
Standard Error 1.51
|
|
PRU Percent Inhibition (Device-reported)
4 hours post-dose
|
84.9 percent inhibition
Standard Error 1.25
|
89.6 percent inhibition
Standard Error 1.58
|
90.2 percent inhibition
Standard Error 1.63
|
79.8 percent inhibition
Standard Error 1.58
|
|
PRU Percent Inhibition (Device-reported)
24 hours post-dose
|
54.1 percent inhibition
Standard Error 2.68
|
81.9 percent inhibition
Standard Error 3.13
|
69.6 percent inhibition
Standard Error 3.18
|
40.0 percent inhibition
Standard Error 3.03
|
|
PRU Percent Inhibition (Device-reported)
48 hours post-dose
|
42.3 percent inhibition
Standard Error 2.79
|
85.8 percent inhibition
Standard Error 3.19
|
58.3 percent inhibition
Standard Error 3.24
|
26.8 percent inhibition
Standard Error 3.19
|
|
PRU Percent Inhibition (Device-reported)
7 days post-dose
|
65.5 percent inhibition
Standard Error 2.17
|
81.0 percent inhibition
Standard Error 3.07
|
65.6 percent inhibition
Standard Error 3.16
|
65.4 percent inhibition
Standard Error 3.02
|
SECONDARY outcome
Timeframe: 2, 4, 24, 48 hours, 7 days after first randomized dosePopulation: Primary population
Analysis of Mean Calculated Percent Inhibition by time point Calculated percent inhibition at time point t is defined as: 100 × (baseline PRU - PRUt)/baseline PRU where baseline PRU is the VerifyNow PRU value at pre-run-in baseline and PRUt is the VerifyNow PRU value at time t.
Outcome measures
| Measure |
Prasugrel Combined Groups
n=65 Participants
combined Prasugrel loading dose and Prasugrel maintenance dose
|
Ticagrelor
n=33 Participants
|
Prasugrel Loading Dose
n=31 Participants
prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
|
Prasugrel Maintenance Dose
n=34 Participants
prasugrel 10 mg QD for 7 days
|
|---|---|---|---|---|
|
PRU Percent Inhibition (Calculated)
2 hours post-dose
|
88.22 Percent Inhibition
Standard Error 1.113
|
89.73 Percent Inhibition
Standard Error 1.476
|
92.55 Percent Inhibition
Standard Error 1.475
|
84.15 Percent Inhibition
Standard Error 1.429
|
|
PRU Percent Inhibition (Calculated)
4 hours post dose
|
85.06 Percent Inhibition
Standard Error 1.319
|
89.26 Percent Inhibition
Standard Error 1.632
|
91.36 Percent Inhibition
Standard Error 1.686
|
79.35 Percent Inhibition
Standard Error 1.605
|
|
PRU Percent Inhibition (Calculated)
24 hours post dose
|
53.63 Percent Inhibition
Standard Error 2.851
|
81.86 Percent Inhibition
Standard Error 3.237
|
71.40 Percent Inhibition
Standard Error 3.291
|
38.01 Percent Inhibition
Standard Error 3.085
|
|
PRU Percent Inhibition (Calculated)
48 hours post dose
|
41.59 Percent Inhibition
Standard Error 2.911
|
85.06 Percent Inhibition
Standard Error 3.388
|
57.98 Percent Inhibition
Standard Error 3.438
|
26.20 Percent Inhibition
Standard Error 3.332
|
|
PRU Percent Inhibition (Calculated)
7 days psot dose
|
64.97 Percent Inhibition
Standard Error 2.336
|
80.69 Percent Inhibition
Standard Error 3.322
|
64.97 Percent Inhibition
Standard Error 3.429
|
64.97 Percent Inhibition
Standard Error 3.221
|
SECONDARY outcome
Timeframe: 2, 4, 24, 48 hours, 7 days after first randomized dosePopulation: Primary population
Percentage of subjects with High on-treatment Platelet Reactivity (HPR) defined as a) \>= 208 PRU and b) \>= 230 PRU by the VerifyNow P2Y12 assay and c) \>50% PRI by the VASP assay, 2, 4, 24, and 48 hours and 7 days after first randomized study treatment. A poor response of the platelets to "drug", called High Residual Platelet Reactivity (HRPR), has been incriminated to account for a recurrence of ischemic events
Outcome measures
| Measure |
Prasugrel Combined Groups
n=65 Participants
combined Prasugrel loading dose and Prasugrel maintenance dose
|
Ticagrelor
n=33 Participants
|
Prasugrel Loading Dose
n=31 Participants
prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
|
Prasugrel Maintenance Dose
n=34 Participants
prasugrel 10 mg QD for 7 days
|
|---|---|---|---|---|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>= 208 PRU 7 days post dose
|
1.5 percentage of subjects
|
3 percentage of subjects
|
3.2 percentage of subjects
|
0 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>50% PRI by VASP assay 7 days post dose
|
15.5 percentage of subjects
|
3.4 percentage of subjects
|
23.1 percentage of subjects
|
9.4 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>= 208 PRU 2 hours post dose
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>= 208 PRU 4 hours post dose
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>= 208 PRU 24 hours post dose
|
17.5 percentage of subjects
|
0 percentage of subjects
|
3.3 percentage of subjects
|
37.5 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>= 208 PRU 48 hours post dose
|
30.2 percentage of subjects
|
0 percentage of subjects
|
16.1 percentage of subjects
|
43.8 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>= 230 PRU by VerifyNow P2Y12 2 hours post dose
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>= 230 PRU by VerifyNow P2Y12 4 hours post dose
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>= 230 PRU by VerifyNow P2Y12 24 hours post dose
|
14.3 percentage of subjects
|
0 percentage of subjects
|
3.3 percentage of subjects
|
24.2 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>= 230 PRU by VerifyNow P2Y12 48 hours post dose
|
22.2 percentage of subjects
|
0 percentage of subjects
|
6.5 percentage of subjects
|
37.5 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>= 230 PRU by VerifyNow P2Y12 7 days post dose
|
1.5 percentage of subjects
|
3 percentage of subjects
|
3.2 percentage of subjects
|
0 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>50% PRI by VASP assay 2 hours post dose
|
3.5 percentage of subjects
|
3.3 percentage of subjects
|
3.6 percentage of subjects
|
3.4 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>50% PRI by VASP assay 4 hours post dose
|
1.8 percentage of subjects
|
3.3 percentage of subjects
|
0 percentage of subjects
|
3.4 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>50% PRI by VASP assay 24 hours post dose
|
21.3 percentage of subjects
|
12.9 percentage of subjects
|
3.4 percentage of subjects
|
37.5 percentage of subjects
|
|
Percentage of Subjects With High On-treatment Platelet Reactivity
>50% PRI by VASP assay 48 hours post dose
|
45 percentage of subjects
|
6.3 percentage of subjects
|
13.8 percentage of subjects
|
74.2 percentage of subjects
|
Adverse Events
Prasugrel Loading Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Prasugrel Maintenance Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Ticagrelor Maintenance Dose
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prasugrel Loading Dose
n=34 participants at risk
Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet
Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets
|
Prasugrel Maintenance Dose
n=41 participants at risk
Prasugrel 10 mg QD MD
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet
|
Ticagrelor Maintenance Dose
n=35 participants at risk
Ticagrelor 90 mg twice-daily (BID) MD
Ticagrelor Maintenance Dose : one 90mg film coated tablet
|
|---|---|---|---|
|
Cardiac disorders
congestive heart failure
|
0.00%
0/34
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
|
Nervous system disorders
depression
|
0.00%
0/34
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/34
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
|
Injury, poisoning and procedural complications
alcohol poisoning
|
0.00%
0/34
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
Other adverse events
| Measure |
Prasugrel Loading Dose
n=34 participants at risk
Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet
Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets
|
Prasugrel Maintenance Dose
n=41 participants at risk
Prasugrel 10 mg QD MD
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet
|
Ticagrelor Maintenance Dose
n=35 participants at risk
Ticagrelor 90 mg twice-daily (BID) MD
Ticagrelor Maintenance Dose : one 90mg film coated tablet
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
eccymosis
|
8.8%
3/34 • Number of events 3
|
12.2%
5/41 • Number of events 5
|
11.4%
4/35 • Number of events 4
|
|
Nervous system disorders
headache
|
2.9%
1/34 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
upper respiratory tract infection
|
2.9%
1/34 • Number of events 1
|
0.00%
0/41
|
5.7%
2/35 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/34
|
0.00%
0/41
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
diarrhoea
|
2.9%
1/34 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
|
Gastrointestinal disorders
periodontal disease
|
0.00%
0/34
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/34
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
costochondritis
|
0.00%
0/34
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/34
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
|
Cardiac disorders
angina pectoris
|
2.9%
1/34 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
|
Eye disorders
vision blurred
|
2.9%
1/34 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
|
Immune system disorders
allergic oedema
|
0.00%
0/34
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/34
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
|
Investigations
alanine aminotransferase increased
|
2.9%
1/34 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
hypomagnesaemia
|
0.00%
0/34
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/34
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
|
General disorders
injection site haematoma
|
0.00%
0/34
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
|
Injury, poisoning and procedural complications
laceration
|
0.00%
0/34
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
|
Injury, poisoning and procedural complications
muscle strain
|
0.00%
0/34
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.00%
0/34
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
Additional Information
Results disclosure agreements
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Restriction type: OTHER