title: Point-of-care measurements of platelet inhibition after clopidogrel loading in patients with acute coronary syndrome: comparison of generic and branded clopidogrel bisulfate.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Kyoung-Woo
authors.initials: KW
authors.lastname: Seo
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea. Electronic address: sjtahk@ajou.ac.kr.
authors.forename: Seung-Jea
authors.initials: SJ
authors.lastname: Tahk
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Hyoung-Mo
authors.initials: HM
authors.lastname: Yang
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Myeong-Ho
authors.initials: MH
authors.lastname: Yoon
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Joon-Han
authors.initials: JH
authors.lastname: Shin
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: So-Yeon
authors.initials: SY
authors.lastname: Choi
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Hong-Seok
authors.initials: HS
authors.lastname: Lim
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Gyo-Seung
authors.initials: GS
authors.lastname: Hwang
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Byoung-Joo
authors.initials: BJ
authors.lastname: Choi
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Jin-Sun
authors.initials: JS
authors.lastname: Park
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Jeoung-Sook
authors.initials: JS
authors.lastname: Shin
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: You-Hong
authors.initials: YH
authors.lastname: Lee
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Yong-Woo
authors.initials: YW
authors.lastname: Choi
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Se-Jun
authors.initials: SJ
authors.lastname: Park
authors.affiliation: Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Xiong-Jie
authors.initials: XJ
authors.lastname: Jin
mesh_terms: D054058:Acute Coronary Syndrome / Q000097:blood / Q000188:drug therapy*; D000368:Aged; D001792:Blood Platelets / Q000187:drug effects*; D000077144:Clopidogrel; D016568:Drugs, Generic / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000494:pharmacology*; D010979:Platelet Function Tests; D000067716:Point-of-Care Testing; D011446:Prospective Studies; D013810:Therapeutic Equivalency; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology
chemical_list: D016568:Drugs, Generic; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine
keywords: acute coronary syndrome; antiplatelet; clopidogrel