title: Comparative effect on platelet function of a fixed-dose aspirin and clopidogrel combination versus separate formulations in patients with coronary artery disease: A phase IV, multicenter, prospective, 4-week non-inferiority trial.
abstract: OBJECTIVE
  The effect of aspirin and clopidogrel in a fixed-dose combination (FDC) on platelet function was compared with separate formulations in patients that had undergone percutaneous coronary intervention (PCI) with drug-eluting stent (DES).
  
  
  METHODS
  This was a phase IV, prospective, multicenter, single-arm, non-inferiority study. Patients that had taken aspirin 100 mg and clopidogrel 75 mg once daily as separate formulations for >6 months after PCI with DES were enrolled, and then switched to an aspirin/clopidogrel FDC once-daily for 4 weeks. Platelet reactivity was determined using the VerifyNow® P2Y12 assay at baseline (immediately prior to switching) and 4 weeks later.
  
  
  RESULTS
  A total of 648 patients (the full-analysis population; age, 63.6±9.0 years; male, 76.5%) finished the study, and 565 (the per-protocol population) completed without protocol violations. In the per-protocol population, the % inhibitions of P2Y12 and ARU were not significantly different between baseline and after 4 weeks of FDC treatment (29.2±20.0% to 29.0±19.9%, P=0.708; 445.1±69.2 to 446.2±63.0, P=0.799, respectively) and the difference in P2Y12 inhibition observed did not exceed the predetermined limit of non-inferiority (95% CI, -0.9 to 1.3). In the full-analysis population, the % inhibitions of P2Y12, PRU, and ARU were not significantly changed after 4 weeks of FDC treatment.
  
  
  CONCLUSIONS
  This study demonstrates that the efficacy of platelet inhibition by an aspirin/clopidogrel FDC was not inferior to that of separate aspirin and clopidogrel formulations in patients that had undergone PCI with DES.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea.
authors.forename: Pyung Chun
authors.initials: PC
authors.lastname: Oh
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea. Electronic address: encore@gilhospital.com.
authors.forename: Taehoon
authors.initials: T
authors.lastname: Ahn
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Republic of Korea.
authors.forename: Dong Woon
authors.initials: DW
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea.
authors.forename: Bum-Kee
authors.initials: BK
authors.lastname: Hong
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Inje University, Busan Paik Hospital, Busan, Republic of Korea.
authors.forename: Dong-Soo
authors.initials: DS
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Inha University Hospital, Incheon, Republic of Korea.
authors.forename: Jun
authors.initials: J
authors.lastname: Kwan
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Incheon, Republic of Korea.
authors.forename: Cheol Ung
authors.initials: CU
authors.lastname: Choi
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Cheongju St. Mary's Hospital, Cheongju, Republic of Korea.
authors.forename: Yong-Mo
authors.initials: YM
authors.lastname: Yang
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Konyang University Hospital, Daejeon, Incheon, Republic of Korea.
authors.forename: Jang Ho
authors.initials: JH
authors.lastname: Bae
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Eulji University Hospital, Daejeon, Republic of Korea.
authors.forename: Kyung Tae
authors.initials: KT
authors.lastname: Jung
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Konkuk University Chungju Hospital, Chungju, Republic of Korea.
authors.forename: Woong Gil
authors.initials: WG
authors.lastname: Choi
authors.affiliation: Division of Cardiology, Department of Internal Medicine, National Health Insurance Corporation Ilsan Hospital, Goyang, Republic of Korea.
authors.forename: Dong Woon
authors.initials: DW
authors.lastname: Jeon
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Myongji Hospital, Goyang, Republic of Korea.
authors.forename: Deok Kyu
authors.initials: DK
authors.lastname: Cho
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea.
authors.forename: Wook Bum
authors.initials: WB
authors.lastname: Pyun
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Busan, Republic of Korea.
authors.forename: Kwang Soo
authors.initials: KS
authors.lastname: Cha
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea.
authors.forename: Tae-Joon
authors.initials: TJ
authors.lastname: Cha
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.
authors.forename: Kook Jin
authors.initials: KJ
authors.lastname: Chun
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Dong-A University Medical Center, Busan, Republic of Korea.
authors.forename: Young Dae
authors.initials: YD
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, DaeDong Hospital, Busan, Republic of Korea.
authors.forename: Byung Soo
authors.initials: BS
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Republic of Korea.
authors.forename: Doo-Il
authors.initials: DI
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Maryknoll Medical Center, Busan, Republic of Korea.
authors.forename: Tae Ik
authors.initials: TI
authors.lastname: Kim
mesh_terms: D001241:Aspirin / Q000008:administration & dosage*; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000188:drug therapy*; D004338:Drug Combinations; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D010979:Platelet Function Tests; D011446:Prospective Studies; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin
keywords: Aspirin; Clopidogrel; Fixed-dose combination; Platelet function