Assessment of the efficacy and tolerability of clopidogrel napadisilate in Korean patients with coronary stenting: a multicenter, prospective, open-label, randomized trial.

AbstractObjective:Clopidogrel is indicated for the treatment and prevention of peripheral vascular, cerebrovascular, and coronary artery diseases. This clinical trial was designed to demonstrate that clopidogrel napadisilate (CN) is not inferior to clopidogrel bisulfate (CB) with respect to its effectiveness in inhibiting platelet aggregation.Methods:This 4 week multi-center, prospective, open-label, randomized trial was conducted at five clinical centers in South Korea. Patients were randomized into the 75 mg CN group or the 75 mg CB group. Platelet aggregation was assessed by the VerifyNow assay. The primary outcome was the difference of the percentage P2Y12 inhibition and the secondary outcome was the baseline and change in P2Y12 reaction units (PRU).Results:There was no significant difference in the percentage P2Y12 inhibition (CN vs. CB, 34.92 ± 21.33% vs. 30.43 ± 17.90%, p = 0.203). The mean difference of the percentage P2Y12 inhibition between groups was 4.49%, their two-sided 95% confidence interv...