Abstract 14668: Antiplatelet Efficacy and Tolerability of Clopidogrel/aspirin Single-Pill Combination in Stable Patients With Coronary Artery Disease Treated With Drug-Eluting Stent Implantation
Background: Closone®, a single-pill combination capsule of clopidogrel bisulfate and aspirin, has been developed to improve patient compliance. We compared the antiplatelet efficacy and safety of Closone® and a combination of clopidogrel bisulfate and aspirin in patients with coronary artery disease undergoing a prior drug-eluting stent implantation.
Methods: This was a phase IV, active controlled, randomized, open-label, parallel, non-inferiority trial. Patients were randomly assigned to either the test group (Closone®) or the control group (clopidogrel 75 mg with aspirin 100 mg) from October 2012 and May 2013 at Seoul St. Mary’s Hospital, Korea. The primary end point was non-inferiority of the percentage of P2Y12 inhibition measured by VeryfyNow P2Y12 assay at 4 weeks after randomization. Changes from baseline in P2Y12 reaction unit (PRU) and in aspirin reaction units (ARU) at 4 weeks as secondary end points were compared between groups.
Results: Of 92 patients enrolled, 82 patients (test, n=42; control, n=40) completed the study. Difference between test and control groups in percentage of P2Y12 inhibitions (mean [SD]) did not exceed the predetermined value for inferiority (test group, 28.61% [16.13%]; control group, 28.00 [19.73%]; 95% CI, -7.96 to 9.19, P for noninferiority<0.001). Difference in pre- and post-treatment ARU between groups did not reach statistical significance (test group, -18.25 ARU [68.85 ARU]; control group, -25.58 ARU [76.42 ARU], P=0.686). In the tolerability analysis, there was no significant differences between groups (test group, 7.3%; control group 5.0%, P>0.99).
Conclusions: We demonstrated that antiplatelet efficacy of Closone® was noninferior to that of clopidogrel with aspirin after 4 weeks of maintenance treatment. No significant difference was found in tolerability between groups.
- © 2013 by American Heart Association, Inc.