Trial Outcomes & Findings for A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin (NCT NCT00528411)
NCT ID: NCT00528411
Last Updated: 2012-01-13
Results Overview
IPA(%)=(PAb-PAt)/PAb\*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
COMPLETED
PHASE2
123 participants
At 2 hours after first dose of study drug
2012-01-13
Participant Flow
Participant milestones
| Measure |
Ticagrelor
Ticagrelor 180 mg loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
|
Clopidogrel
Clopidogrel 600 mg loading dose followed by 75 mg Twice Daily (od), plus ticagrelor placebo loading and Once Daily (bd) maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
54
|
12
|
|
Overall Study
COMPLETED
|
52
|
51
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
1
|
Reasons for withdrawal
| Measure |
Ticagrelor
Ticagrelor 180 mg loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
|
Clopidogrel
Clopidogrel 600 mg loading dose followed by 75 mg Twice Daily (od), plus ticagrelor placebo loading and Once Daily (bd) maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
1
|
|
Overall Study
Incorrect Enrolment
|
1
|
1
|
0
|
|
Overall Study
Severe non-compliance to protocol
|
0
|
1
|
0
|
|
Overall Study
Prior commitment medication
|
0
|
1
|
0
|
Baseline Characteristics
A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin
Baseline characteristics by cohort
| Measure |
Ticagrelor
n=57 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus Clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=54 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
62.2 Year
STANDARD_DEVIATION 9.10 • n=5 Participants
|
65.4 Year
STANDARD_DEVIATION 7.98 • n=7 Participants
|
63.9 Year
STANDARD_DEVIATION 8.32 • n=5 Participants
|
63.8 Year
STANDARD_DEVIATION 8.62 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At 2 hours after first dose of study drugPopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=48 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=49 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose
|
93.15 Percentage
Interval 80.4 to 100.0
|
31.05 Percentage
Interval 10.3 to 56.9
|
—
|
PRIMARY outcome
Timeframe: 4 to 72 Hours after last dose of study drugPopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. The unit for the slope of IPA curve is percent/hour.
Outcome measures
| Measure |
Ticagrelor
n=54 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=50 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug
|
-1.037 Percentage/Hour
Standard Error 0.076 • Interval 0.076 to
|
-0.482 Percentage/Hour
Standard Error 0.055 • Interval 0.055 to
|
—
|
SECONDARY outcome
Timeframe: 0.5 hours after first dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=49 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=47 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose
|
45.39 Percentage
Interval 3.0 to 66.4
|
4.71 Percentage
Interval 0.0 to 14.8
|
—
|
SECONDARY outcome
Timeframe: 1 hour after first dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=47 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=47 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose
|
86.71 Percentage
Interval 72.6 to 99.4
|
15.83 Percentage
Interval 0.0 to 32.5
|
—
|
SECONDARY outcome
Timeframe: 4 hours after first dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=49 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=48 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose
|
98.39 Percentage
Interval 84.2 to 100.0
|
40.87 Percentage
Interval 16.6 to 69.3
|
—
|
SECONDARY outcome
Timeframe: 8 hours after first dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=53 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=47 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose
|
96.99 Percentage
Interval 81.1 to 100.0
|
46.90 Percentage
Interval 20.4 to 80.8
|
—
|
SECONDARY outcome
Timeframe: 24 hours after first dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=52 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=46 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose
|
87.29 Percentage
Interval 62.9 to 98.4
|
49.64 Percentage
Interval 17.7 to 76.9
|
—
|
SECONDARY outcome
Timeframe: 0 hour before last dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=44 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=42 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose
|
74.53 Percentage
Interval 56.5 to 98.3
|
51.75 Percentage
Interval 32.8 to 66.4
|
—
|
SECONDARY outcome
Timeframe: 2 hours after last dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=45 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=43 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose
|
91.49 Percentage
Interval 83.0 to 100.0
|
62.96 Percentage
Interval 35.2 to 78.8
|
—
|
SECONDARY outcome
Timeframe: 4 hours after last dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=47 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=44 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose
|
96.10 Percentage
Interval 80.4 to 100.0
|
61.80 Percentage
Interval 35.2 to 88.4
|
—
|
SECONDARY outcome
Timeframe: 8 hours after last dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=47 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=44 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose
|
88.31 Percentage
Interval 77.3 to 100.0
|
61.31 Percentage
Interval 39.0 to 61.31
|
—
|
SECONDARY outcome
Timeframe: 24 hours after last dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=48 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=45 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose
|
55.18 Percentage
Interval 39.1 to 85.4
|
53.91 Percentage
Interval 35.1 to 73.3
|
—
|
SECONDARY outcome
Timeframe: 48 hours after last dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=49 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=43 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose
|
30.94 Percentage
Interval 14.3 to 51.5
|
45.79 Percentage
Interval 19.4 to 54.7
|
—
|
SECONDARY outcome
Timeframe: 72 hours after last dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=49 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=42 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose
|
11.76 Percentage
Interval 0.0 to 34.5
|
21.09 Percentage
Interval 10.2 to 47.6
|
—
|
SECONDARY outcome
Timeframe: 120 hours - Day 5 after last dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=49 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=41 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose
|
0.0 Percentage
Interval 0.0 to 15.2
|
21.15 Percentage
Interval 0.0 to 34.7
|
—
|
SECONDARY outcome
Timeframe: 168 hours - Day 7 after last dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference of baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=47 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=41 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose
|
0.0 Percentage
Interval 0.0 to 11.7
|
6.32 Percentage
Interval 0.0 to 22.4
|
—
|
SECONDARY outcome
Timeframe: 240 hours - Day 10 after last dosePopulation: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Outcome measures
| Measure |
Ticagrelor
n=48 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=44 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose
|
1.64 Percentage
Interval 0.0 to 9.9
|
0.98 Percentage
Interval 0.0 to 13.8
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
FEV1 is measured by Spirometry, the unit is Liter.
Outcome measures
| Measure |
Ticagrelor
n=57 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=54 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)
|
2.79 Liter
Standard Deviation 0.725
|
2.71 Liter
Standard Deviation 0.791
|
2.94 Liter
Standard Deviation 0.654
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
FEV1 is measured by Spirometry, the unit is Liter.
Outcome measures
| Measure |
Ticagrelor
n=53 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=51 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=11 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Post 6-week Treatment: FEV1
|
2.77 Liter
Standard Deviation 0.712
|
2.74 Liter
Standard Deviation 0.751
|
2.95 Liter
Standard Deviation 0.727
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
FVC is measured by Spirometry, the unit is Liter.
Outcome measures
| Measure |
Ticagrelor
n=57 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=54 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)
|
3.72 Liter
Standard Deviation 0.903
|
3.73 Liter
Standard Deviation 1.082
|
4.03 Liter
Standard Deviation 0.858
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
FVC is measured by Spirometry, the unit is Liter.
Outcome measures
| Measure |
Ticagrelor
n=53 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=51 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=11 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Post 6-week Treatment: FVC
|
3.70 Liter
Standard Deviation 0.933
|
3.78 Liter
Standard Deviation 1.029
|
3.98 Liter
Standard Deviation 0.890
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.
Outcome measures
| Measure |
Ticagrelor
n=57 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=54 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio)
|
75.01 Ratio
Standard Deviation 7.049
|
73.04 Ratio
Standard Deviation 6.764
|
73.13 Ratio
Standard Deviation 7.226
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.
Outcome measures
| Measure |
Ticagrelor
n=53 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=51 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=11 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio
|
74.71 Ratio
Standard Deviation 5.694
|
72.84 Ratio
Standard Deviation 6.371
|
74.27 Ratio
Standard Deviation 7.836
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Outcome measures
| Measure |
Ticagrelor
n=57 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=54 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75)
|
2.88 Liter/second
Standard Deviation 1.251
|
2.70 Liter/second
Standard Deviation 1.208
|
2.50 Liter/second
Standard Deviation 1.243
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Outcome measures
| Measure |
Ticagrelor
n=53 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=51 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=11 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75
|
2.77 Liter/second
Standard Deviation 1.289
|
2.67 Liter/second
Standard Deviation 1.156
|
2.91 Liter/second
Standard Deviation 1.375
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
FRC is measured by Body Box Plethysmography, the unit is Liter.
Outcome measures
| Measure |
Ticagrelor
n=55 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=53 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)
|
2.79 Liter
Standard Deviation 0.827
|
2.89 Liter
Standard Deviation 0.876
|
2.91 Liter
Standard Deviation 0.679
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
FRC is measured by Body Box Plethysmography, the unit is Liter.
Outcome measures
| Measure |
Ticagrelor
n=53 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=51 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=11 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters Post 6-week Treatment: FRC
|
2.73 Liter
Standard Deviation 0.723
|
2.79 Liter
Standard Deviation 0.857
|
2.75 Liter
Standard Deviation 1.000
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
TLC is measured by Body Box Plethysmography, the unit is Liter.
Outcome measures
| Measure |
Ticagrelor
n=55 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=53 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)
|
5.78 Liter
Standard Deviation 1.299
|
5.83 Liter
Standard Deviation 1.401
|
6.10 Liter
Standard Deviation 1.037
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
TLC is measured by Body Box Plethysmography, the unit is Liter.
Outcome measures
| Measure |
Ticagrelor
n=53 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=51 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=11 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters Post 6-week Treatment: TLC
|
5.70 Liter
Standard Deviation 1.182
|
5.85 Liter
Standard Deviation 1.396
|
5.96 Liter
Standard Deviation 1.422
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
RV is measured by Body Box Plethysmography, the unit is Liter.
Outcome measures
| Measure |
Ticagrelor
n=55 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=53 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: Residual Volume (RV)
|
1.94 Liter
Standard Deviation 0.780
|
2.01 Liter
Standard Deviation 0.643
|
1.91 Liter
Standard Deviation 0.363
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
RV is measured by Body Box Plethysmography, the unit is Liter.
Outcome measures
| Measure |
Ticagrelor
n=53 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=51 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=11 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters Post 6-week Treatment: RV
|
1.88 Liter
Standard Deviation 0.621
|
1.97 Liter
Standard Deviation 0.559
|
1.90 Liter
Standard Deviation 0.751
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Outcome measures
| Measure |
Ticagrelor
n=55 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=50 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)
|
12.92 Liter/minute
Standard Deviation 3.950
|
12.17 Liter/minute
Standard Deviation 3.552
|
12.06 Liter/minute
Standard Deviation 4.054
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Outcome measures
| Measure |
Ticagrelor
n=53 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=50 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=11 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters Post 6-week Treatment: VE
|
13.69 Liter/minute
Standard Deviation 3.582
|
13.14 Liter/minute
Standard Deviation 5.515
|
11.45 Liter/minute
Standard Deviation 3.540
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Outcome measures
| Measure |
Ticagrelor
n=57 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=54 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)
|
14.79 Breaths/minute
Standard Deviation 2.433
|
14.15 Breaths/minute
Standard Deviation 2.743
|
15.5 Breaths/minute
Standard Deviation 1.977
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Outcome measures
| Measure |
Ticagrelor
n=53 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=52 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=11 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters Post 6-week Treatment: RR
|
15.21 Breaths/minute
Standard Deviation 2.817
|
15.10 Breaths/minute
Standard Deviation 2.303
|
14.91 Breaths/minute
Standard Deviation 0.944
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
VT is measured by Body Box Plethysmography, the unit is Liter/Minute.
Outcome measures
| Measure |
Ticagrelor
n=55 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=50 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)
|
0.96 Liters/minute
Standard Deviation 0.326
|
0.89 Liters/minute
Standard Deviation 0.322
|
0.89 Liters/minute
Standard Deviation 0.273
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
VT is measured by Body Box Plethysmography, the unit is Liter/Minute.
Outcome measures
| Measure |
Ticagrelor
n=53 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=50 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=11 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters Post 6-week Treatment: VT
|
0.92 Liters/minute
Standard Deviation 0.264
|
0.93 Liters/minute
Standard Deviation 0.393
|
0.83 Liters/minute
Standard Deviation 0.329
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
Outcome measures
| Measure |
Ticagrelor
n=57 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=54 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB)
|
17.00 Percent
Standard Deviation 8.673
|
17.29 Percent
Standard Deviation 10.891
|
15.83 Percent
Standard Deviation 6.013
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
Outcome measures
| Measure |
Ticagrelor
n=53 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=51 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=11 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB
|
16.38 Percent
Standard Deviation 8.090
|
16.53 Percent
Standard Deviation 8.286
|
16.09 Percent
Standard Deviation 7.190
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.
Outcome measures
| Measure |
Ticagrelor
n=57 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=54 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF)
|
57.96 Percent
Standard Deviation 9.302
|
61.91 Percent
Standard Deviation 7.624
|
59.92 Percent
Standard Deviation 10.013
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.
Outcome measures
| Measure |
Ticagrelor
n=53 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=52 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=11 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters Post 6-week Treatment: EF
|
60.70 Percent
Standard Deviation 8.430
|
62.38 Percent
Standard Deviation 7.096
|
60.73 Percent
Standard Deviation 9.665
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
NT-proBNP is measured by clinical lab, the unit is pg/mL.
Outcome measures
| Measure |
Ticagrelor
n=52 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=53 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
|
163.34 pg/ml
Standard Deviation 184.298
|
185.98 pg/ml
Standard Deviation 227.141
|
145.41 pg/ml
Standard Deviation 144.522
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
NT-proBNP is measured by clinical lab, the unit is pg/mL.
Outcome measures
| Measure |
Ticagrelor
n=43 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=48 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=11 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP
|
139.88 pg/ml
Standard Deviation 170.347
|
214.43 pg/ml
Standard Deviation 313.429
|
140.68 pg/ml
Standard Deviation 145.003
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.
Outcome measures
| Measure |
Ticagrelor
n=56 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=54 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2)
|
96.59 Percent
Standard Deviation 1.570
|
96.78 Percent
Standard Deviation 1.949
|
97.58 Percent
Standard Deviation 1.240
|
SECONDARY outcome
Timeframe: 6-week post treatmentPopulation: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.
Outcome measures
| Measure |
Ticagrelor
n=52 Participants
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=51 Participants
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=9 Participants
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiopulmonary Parameters Post 6-week Treatment: SpO2
|
97.73 Percentage
Standard Deviation 1.239
|
97.35 Percentage
Standard Deviation 1.262
|
98.56 Percentage
Standard Deviation 1.014
|
Adverse Events
Ticagrelor
Clopidogrel
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ticagrelor
n=57 participants at risk
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
Clopidogrel
n=54 participants at risk
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
|
Placebo
n=12 participants at risk
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
|
|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
5.3%
3/57
|
1.9%
1/54
|
0.00%
0/12
|
|
Cardiac disorders
Palpitations
|
5.3%
3/57
|
0.00%
0/54
|
0.00%
0/12
|
|
Eye disorders
Visual Impairment
|
0.00%
0/57
|
0.00%
0/54
|
8.3%
1/12
|
|
Gastrointestinal disorders
Dyspepsia
|
3.5%
2/57
|
0.00%
0/54
|
8.3%
1/12
|
|
Gastrointestinal disorders
Abdominal Wall Haematoma
|
0.00%
0/57
|
0.00%
0/54
|
8.3%
1/12
|
|
General disorders
Vessel Puncture Site Haematoma
|
5.3%
3/57
|
9.3%
5/54
|
8.3%
1/12
|
|
General disorders
Fatigue
|
7.0%
4/57
|
3.7%
2/54
|
8.3%
1/12
|
|
General disorders
Oedema Peripheral
|
7.0%
4/57
|
3.7%
2/54
|
0.00%
0/12
|
|
General disorders
Chest Discomfort
|
1.8%
1/57
|
0.00%
0/54
|
8.3%
1/12
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
4/57
|
7.4%
4/54
|
0.00%
0/12
|
|
Infections and infestations
Cellulitis
|
0.00%
0/57
|
0.00%
0/54
|
8.3%
1/12
|
|
Injury, poisoning and procedural complications
Contusion
|
10.5%
6/57
|
5.6%
3/54
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Electrocardiogram Poor R-Wave Progression
|
0.00%
0/57
|
0.00%
0/54
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
4/57
|
1.9%
1/54
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/57
|
0.00%
0/54
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/57
|
1.9%
1/54
|
8.3%
1/12
|
|
Nervous system disorders
Dizziness
|
1.8%
1/57
|
3.7%
2/54
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
35.1%
20/57
|
11.1%
6/54
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
5.3%
3/57
|
0.00%
0/54
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
3/57
|
0.00%
0/54
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Increased Tendency To Bruise
|
15.8%
9/57
|
3.7%
2/54
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/57
|
0.00%
0/54
|
8.3%
1/12
|
|
Vascular disorders
Hypertension
|
5.3%
3/57
|
1.9%
1/54
|
0.00%
0/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee An Investigator agrees to provide a copy of the publication to AZ for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites.
- Publication restrictions are in place
Restriction type: OTHER