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

Abstract

Objective: 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 P2Y(12) inhibition and the secondary outcome was the baseline and change in P2Y(12) reaction units (PRU). Results: There was no significant difference in the percentage P2Y(12) inhibition (CN vs. CB, 34.92 +/- 21.33% vs. 30.43 +/- 17.90%, p = 0.203). The mean difference of the percentage P2Y(12) inhibition between groups was 4.49%, their two-sided 95% confidence interval was -2.45% to 11.44%, and the lower bound (-2.45%) was greater than the acceptable non-inferiority margin of -9.0%. The baseline PRU was 96.67 +/- 76.76 in the CN group and 216.95 +/- 68.86 in the CB group (p = 0.121), and the change in the PRU was -3.32 +/- 51.71 in the CN group and 10.52 +/- 43.31 in the CB group (p = 0.106). Four subjects experienced AEs (6.3%, 5 events) in the CN group and 7 subjects (11.11%, 13 events) in the CB group without statistical significance (p = 0.364). With respect to serious adverse events, 2 events were reported in 2 subjects, 1 in each group. Conclusion: Clopidogrel napadisilate was not inferior to clopidogrel bisulfate in terms of antiplatelet efficacy and tolerability, and there were no clinically significant adverse events.