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

Pyung Chun Oh, Taehoon Ahn, Dong Woon Kim, Bum Kee Hong, Dong Soo Kim, Jun Kwan, Cheol Ung Choi, Yong Mo Yang, Jang Ho Bae, Kyung Tae Jung, Woong Gil Choi, Dong Woon Jeon, Deok Kyu Cho, Wook Bum Pyun, Kwang Soo Cha, Tae Joon Cha, Kook Jin Chun, Young Dae Kim, Byung Soo Kim, Doo Il KimTae Ik Kim

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2 Citations (Scopus)

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). 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.

Original languageEnglish
Pages (from-to)331-335
Number of pages5
JournalInternational Journal of Cardiology
Volume202
DOIs
Publication statusPublished - 2016 Jan 1

Keywords

  • Aspirin
  • Clopidogrel
  • Fixed-dose combination
  • Platelet function

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Oh, P. C., Ahn, T., Kim, D. W., Hong, B. K., Kim, D. S., Kwan, J., Choi, C. U., Yang, Y. M., Bae, J. H., Jung, K. T., Choi, W. G., Jeon, D. W., Cho, D. K., Pyun, W. B., Cha, K. S., Cha, T. J., Chun, K. J., Kim, Y. D., Kim, B. S., ... Kim, T. I. (2016). 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. International Journal of Cardiology, 202, 331-335. https://doi.org/10.1016/j.ijcard.2015.09.024