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Phase 4 Completed N=302 Randomized Treatment

Clopidogrel and Aspirin Interaction Study-2

Drug Action Increased
Source: ClinicalTrials.gov NCT01341964 ↗
Enrolled (actual)
302
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Blood Concentration of the Active Metabolite of Clopidogrel — 14.45; 13.80 ng/ml — p=0.66
◆ Published Evidence
Emerging
11citations · ~1 / year
Active metabolite concentration of clopidogrel in patients taking different doses of aspirin: results of the interaction trial.
Journal of thrombosis and haemostasis : JTH · 2015 · Open access · Likely link

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.

Linked Publications

  • Active metabolite concentration of clopidogrel in patients taking different doses of aspirin: results of the interaction trial.
    Journal of thrombosis and haemostasis : JTH · 2015 · 11 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Blood Concentration of the Active Metabolite of Clopidogrel
14.45; 13.80 0.66

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01341964) and the linked publication. 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. Informational only — not medical advice.

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