Comparison of Effect & Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients

Summary

The aim of this study is to demonstrate that the combination therapy of aspirin and clopidogrel napadisilate is not inferior to that of aspirin and clopidogrel bisulfate with respect to its effectiveness in inhibiting platelet aggregation, if it is given for four weeks to Coronary Artery Disease (CAD) patients who had been treated with a drug-eluting stent before \> 12 months and had remained in a stable condition with a single antiplatelet agent, aspirin.

Timeline

Start

2009-03

Primary completion

2009-08

Completion

2009-12

Outcome

Met primary endpoint

paper (-5.46) was greater than the pre-defined non-inferiority margin of (-10.5). PMID 23913405 ↗

Publications

• Lee S, Lee HY, Park KW, Kang HJ, Koo BK, Kim HS, Choi DJ, Kim MA, Oh BH. Comparison of antiplatelet effect and safety of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients: multi-center, randomized, double-blind, phase IV, non-inferiority clinical trial. Am J Cardiovasc Drugs. 2013 Dec;13(6):413-24. doi: 10.1007/s40256-013-0039-y.

Drugs

Indications