Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting

Phase 4 Completed 148 enrolled Seoul National University Hospital Hanmi Pharmaceutical Company Limited · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of the current study is to compare the antiplatelet efficacy and safety of clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients after coronary stent implantation.

Timeline

Start: 2010-10
Primary completion: 2012-02
Completion: —

Outcome

Met primary endpoint

paper The between-group difference in percentage of P2Y(12) inhibition did not exceed the prespecified limit for noninferiority (P for noninferiority = 0.032; 95% CI, -8.33 to 5.53). PMID 23328268 ↗

paper the antiplatelet efficacy of clopidogrel napadisilate was noninferior to that of clopidogrel bisulfate after 4 weeks of maintenance treatment. PMID 23328268 ↗

Publications

Park JB, Koo BK, Choi WG, Kim SY, Park J, Kwan J, Park CG, Kim HS. Comparison of antiplatelet efficacy and tolerability of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients after percutaneous coronary intervention: a prospective, multicenter, randomized, open-label, phase IV, noninferiority trial. Clin Ther. 2013 Jan;35(1):28-37.e4. doi: 10.1016/j.clinthera.2012.12.004.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clopidogrel	Small molecule	75 mg	—
Background	Aspirin	Small molecule	100 mg	—