title: Pharmacodynamic effects of a new fixed-dose clopidogrel-aspirin combination compared with separate administration of clopidogrel and aspirin in patients treated with coronary stents: The ACCEL-COMBO trial.
abstract: Dual antiplatelet therapy (DAPT) with clopidogrel and aspirin is a widely prescribed regimen to prevent ischemic events in patients undergoing percutaneous coronary intervention (PCI). A fixed-dose combination (FDC) capsule (HCP0911) has been developed to provide dosing convenience and improve adherence. We compared the antiplatelet effects of single daily dose HCP0911 with separate treatment with daily 75 mg clopidogrel plus 100 mg aspirin. This was a randomized, open-label, two-period, crossover, non-inferiority study conducted in stented patients who had been treated for at least 6 months with clopidogrel and aspirin. Thirty patients were randomly assigned to receive either daily 75 mg clopidogrel plus 100 mg aspirin treatment or HCP0911 for 2 weeks and then were crossed over to the other treatment for 2 weeks. Pharmacodynamic effects were measured with VerifyNow, light transmittance aggregometry (LTA), and thromboelastography (TEG®). The primary endpoint was P2Y12 Reaction Units (PRU) measured by VerifyNow. PRUs during treatment with HCP0911 were not inferior to those during separate treatment (202 ± 52 vs. 207 ± 60 PRU; mean difference, -5 PRU; 90% confidence interval of difference, -23 to 13 PRU; P for non-inferiority = 0.015 for predetermined limit). "BASE" and Aspirin Reaction Units by VerifyNow did not differ between the two treatments. During each treatment, there were no differences in maximal and final platelet aggregations by LTA (all P values ≥0.822) and TEG®measurements. In conclusion, in stented patients, the antiplatelet effect of a fixed-dose clopidogrel-aspirin combination, HCP0911, was not inferior to separate administration of clopidogrel and aspirin.
authors: a Department of Internal Medicine , Gyeongsang National University School of Medicine and Gyeongsang National University Hospital , Jinju , Republic of Korea.
authors: Jin-Sin
authors: JS
authors: Koh
authors: b Department of Internal Medicine , Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital , Changwon , Republic of Korea.
authors: Yongwhi
authors: Y
authors: Park
authors: c Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute , Fairfax , VA , USA.
authors: Udaya S
authors: US
authors: Tantry
authors: b Department of Internal Medicine , Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital , Changwon , Republic of Korea.
authors: Jong-Hwa
authors: JH
authors: Ahn
authors: a Department of Internal Medicine , Gyeongsang National University School of Medicine and Gyeongsang National University Hospital , Jinju , Republic of Korea.
authors: Min Gyu
authors: MG
authors: Kang
authors: a Department of Internal Medicine , Gyeongsang National University School of Medicine and Gyeongsang National University Hospital , Jinju , Republic of Korea.
authors: Kyehwan
authors: K
authors: Kim
authors: b Department of Internal Medicine , Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital , Changwon , Republic of Korea.
authors: Jeong Yoon
authors: JY
authors: Jang
authors: a Department of Internal Medicine , Gyeongsang National University School of Medicine and Gyeongsang National University Hospital , Jinju , Republic of Korea.
authors: Hyun Woong
authors: HW
authors: Park
authors: a Department of Internal Medicine , Gyeongsang National University School of Medicine and Gyeongsang National University Hospital , Jinju , Republic of Korea.
authors: Jeong Rang
authors: JR
authors: Park
authors: a Department of Internal Medicine , Gyeongsang National University School of Medicine and Gyeongsang National University Hospital , Jinju , Republic of Korea.
authors: Seok-Jae
authors: SJ
authors: Hwang
authors: b Department of Internal Medicine , Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital , Changwon , Republic of Korea.
authors: Choong Hwan
authors: CH
authors: Kwak
authors: a Department of Internal Medicine , Gyeongsang National University School of Medicine and Gyeongsang National University Hospital , Jinju , Republic of Korea.
authors: Jin-Yong
authors: JY
authors: Hwang
authors: c Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute , Fairfax , VA , USA.
authors: Paul A
authors: PA
authors: Gurbel
authors: b Department of Internal Medicine , Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital , Changwon , Republic of Korea.|d Institute of the Health Sciences , Gyeongsang National University , Jinju , Republic of Korea.
authors: Young-Hoon
authors: YH
authors: Jeong
mesh_terms: D054058:Acute Coronary Syndrome / Q000097:blood / Q000628:therapy*; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D000077144:Clopidogrel; D015897:Comorbidity; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects; D010974:Platelet Aggregation / Q000187:drug effects; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics; D010979:Platelet Function Tests; D015607:Stents / Q000009:adverse effects; D013916:Thrombelastography; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin
keywords: Aspirin; aggregation; clopidogrel; platelet