Clopidogrel and Aspirin Interaction Study-2

NCT01341964 ↗

Phase 4 Completed 302 enrolled Population Health Research Institute

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2011-05
Primary completion: 2013-04
Completion: 2013-04

Outcome

Missed primary endpoint

registry analysis (superiority test); Clopidogrel Concentration of Higher Dose Aspirin Group vs Clopidogrel Concentration of Low Dose Aspirin Group; p = 0.66; Median Difference (Final Values) 0.05; t-test, 2 sided NCT01341964 ↗

Publications

Liang Y, Hirsh J, Weitz JI, Sloane D, Gao P, Pare G, Zhu J, Eikelboom JW. Active metabolite concentration of clopidogrel in patients taking different doses of aspirin: results of the interaction trial. J Thromb Haemost. 2015 Mar;13(3):347-52. doi: 10.1111/jth.12829. Epub 2015 Feb 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aspirin	Small molecule	81 mg	—
Comparator	Aspirin	Small molecule	325 mg	—
Subject	Clopidogrel	Small molecule	600 mg	—

Indications

No indication recorded.