Phase 4
N=302
Clopidogrel and Aspirin Interaction Study-2
Drug Action Increased
Bottom Line
View on ClinicalTrials.gov: NCT01341964 ↗Enrolled (actual)
302
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Blood Concentration of the Active Metabolite of Clopidogrel — 14.45; 13.80 ng/ml — p=0.66
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Clopidogrel (Drug); Aspirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Population Health Research Institute
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Concentration of the Active Metabolite of Clopidogrel |
14.45; 13.80 | 0.66 |
Summary
Clopidogrel and aspirin are commonly used in combination to prevent heart attacks and to prevent blockage of stents. Both clopidogrel and aspirin work by preventing platelets (sticky cells that circulate in the blood) from forming blood clots in the arteries supplying oxygen to the heart and in stents. The investigators hypothesize that aspirin 325mg compared with aspirin 81 mg will increase blood levels of the active metabolite of clopidogrel in patients with a history of coronary artery disease who receive a 600mg loading dose of clopidogrel.
Eligibility Criteria
Inclusion Criteria
- Stable patients >1 month post ACS (including ST elevated myocardial infarction, non-ST elevated myocardial infarction or unstable angina) or stent
- Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week
- Written informed consent
Exclusion Criteria
- Age 2x upper limits of normal (ULN)*
- Renal impairment with creatinine clearance =180/110mmHg)
- within 3 months of planned randomization
Data sourced from ClinicalTrials.gov (NCT01341964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.