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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.
- Source :
-
International journal of cardiology [Int J Cardiol] 2016 Jan 01; Vol. 202, pp. 331-5. Date of Electronic Publication: 2015 Sep 21. - Publication Year :
- 2016
-
Abstract
- Background/objectives: 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).<br />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.<br />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.<br />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.<br /> (Copyright © 2015. Published by Elsevier Ireland Ltd.)
- Subjects :
- Clopidogrel
Drug Combinations
Drug-Eluting Stents
Female
Humans
Male
Middle Aged
Platelet Function Tests
Prospective Studies
Ticlopidine administration & dosage
Treatment Outcome
Aspirin administration & dosage
Coronary Artery Disease drug therapy
Platelet Aggregation Inhibitors administration & dosage
Ticlopidine analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1874-1754
- Volume :
- 202
- Database :
- MEDLINE
- Journal :
- International journal of cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 26432484
- Full Text :
- https://doi.org/10.1016/j.ijcard.2015.09.024