Trial Outcomes & Findings for Clopidogrel and Aspirin Interaction Study-2 (NCT NCT01341964)
NCT ID: NCT01341964
Last Updated: 2023-07-27
Results Overview
Clopidogrel active metabolite concentration will be measured by liquid chromatography tandem mass spectrometry (LC/MS) methods.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
302 participants
Primary outcome timeframe
1 hour after loading dose of study medications
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
Higher Dose Aspirin Group
Clopidogrel 600 mg plus aspirin 325mg
Clopidogrel: 600mg (2 pills)
Aspirin: 325mg (1 pill)
|
Low Dose Aspirin Group
Clopidogrel 600mg plus aspirin 81mg
Clopidogrel: 600mg (2 pills)
Aspirin: 81mg (1 pill)
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
150
|
|
Overall Study
COMPLETED
|
152
|
150
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clopidogrel and Aspirin Interaction Study-2
Baseline characteristics by cohort
| Measure |
Higher Dose Aspirin Group
n=152 Participants
Clopidogrel 600 mg plus aspirin 325mg
Clopidogrel: 600mg (2 pills)
Aspirin: 325mg (1 pill)
|
Low Dose Aspirin Group
n=150 Participants
Clopidogrel 600mg plus aspirin 81mg
Clopidogrel: 600mg (2 pills)
Aspirin: 81mg (1 pill)
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age (years)
|
59.3 years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
61.5 years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
60.4 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
216 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 hour after loading dose of study medicationsClopidogrel active metabolite concentration will be measured by liquid chromatography tandem mass spectrometry (LC/MS) methods.
Outcome measures
| Measure |
Clopidogrel Concentration of Higher Dose Aspirin Group
n=147 Participants
Clopidogrel 600 mg plus aspirin 325mg
Clopidogrel: 600mg (2 pills)
Aspirin: 325mg (1 pill)
|
Clopidogrel Concentration of Low Dose Aspirin Group
n=143 Participants
Clopidogrel 600mg plus aspirin 81mg
Clopidogrel: 600mg (2 pills)
Aspirin: 81mg (1 pill)
|
|---|---|---|
|
Blood Concentration of the Active Metabolite of Clopidogrel
|
14.45 ng/ml
Interval 6.58 to 24.2
|
13.80 ng/ml
Interval 7.62 to 20.2
|
Adverse Events
Clopidogrel Concentration of Higher Dose Aspirin Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clopidogrel Concentration of Low Dose Aspirin Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lynda Hill
Population Health Reseach Institute, Hamilton, ON, Canada
Phone: 905-297-3479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place