Point-of-care measurements of platelet inhibition after clopidogrel loading in patients with acute coronary syndrome: comparison of generic and branded clopidogrel bisulfate.

Abstract

PURPOSE: Platelet-function suppression with antiplatelet therapy is effective in

preventing and treating cardiovascular disease. Clopidogrel is a thienopyridine

derivative that blocks platelet activation by adenosine diphosphate receptor

binding. This study demonstrates the effects of generic clopidogrel bisulfate in

comparison to branded clopidogrel bisulfate in patients with acute coronary

syndromes. METHODS: This prospective, 2-arm, single-center, open-label trial used

1:1 randomization to assign patients to receive generic or branded clopidogrel

bisulfate. Patients with unstable angina or non-ST-segment elevation myocardial

infarction and scheduled to undergo coronary angiography were enrolled. Platelet

function was measured with a P2Y12 assay and reported in P2Y12 reaction units

(PRU) and aspirin reaction units (ARU) after randomization. Platelet function was

measured at 2, 4, 8, and 24 hours after 600-mg clopidogrel loading. The clinical

outcome was checked at 1 month after coronary angiography. FINDINGS: Ninety-five

patients were enrolled and randomized to the generic or branded group. Ninety

patients (62 men [69%], 28 women [31%]; mean age, 58 years) completed the study

protocol. The clinical characteristics were similar between the 2 groups. The

difference in the baseline PRU measurements between the generic and branded

groups was not significant (274.8 [59.7] vs 285.4 [62.4], respectively; P =

0.414). There were significant differences in 2-hour PRU (231.1 [71.3] vs 266.9

[67.4]; P = 0.017) and 4-hour PRU (227.3 [80.4] vs 265.7 [71.0]; P = 0.020);

however, 24-hour PRU (200.5 [82.1] vs 220.6 [75.8]; P = 0.253) was similar. No

death, myocardial infarction, target lesion revascularization, stent thrombosis,

or Thrombolysis in Myocardial Infarction-defined major bleeding complications

were reported during in-hospital stay or 1-month follow-up. IMPLICATION: In

patients with ACS, loading of generic clopidogrel bisulfate was associated with

an antiplatelet effect comparable to that of branded clopidogrel bisulfate.

ClinicalTrials.gov identifier: NCT02060786.

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