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 Kim & 1 others Tae Ik Kim

Research output: Contribution to journalArticle

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

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clopidogrel
Aspirin
Coronary Artery Disease
Blood Platelets
Drug-Eluting Stents
Percutaneous Coronary Intervention
Population

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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

In: International Journal of Cardiology, Vol. 202, 01.01.2016, p. 331-335.

Research output: Contribution to journalArticle

Oh, PC, Ahn, T, Kim, DW, Hong, BK, Kim, DS, Kwan, J, Choi, CU, Yang, YM, Bae, JH, Jung, KT, Choi, WG, Jeon, DW, Cho, DK, Pyun, WB, Cha, KS, Cha, TJ, Chun, KJ, Kim, YD, Kim, BS, Kim, DI & Kim, TI 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, vol. 202, pp. 331-335. https://doi.org/10.1016/j.ijcard.2015.09.024
Oh, Pyung Chun ; Ahn, Taehoon ; Kim, Dong Woon ; Hong, Bum Kee ; Kim, Dong Soo ; Kwan, Jun ; Choi, Cheol Ung ; Yang, Yong Mo ; Bae, Jang Ho ; Jung, Kyung Tae ; Choi, Woong Gil ; Jeon, Dong Woon ; Cho, Deok Kyu ; Pyun, Wook Bum ; Cha, Kwang Soo ; Cha, Tae Joon ; Chun, Kook Jin ; Kim, Young Dae ; Kim, Byung Soo ; Kim, Doo Il ; Kim, Tae Ik. / 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. In: International Journal of Cardiology. 2016 ; Vol. 202. pp. 331-335.
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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{\circledR} 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.",
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T1 - Comparative effect on platelet function of a fixed-dose aspirin and clopidogrel combination versus separate formulations in patients with coronary artery disease

T2 - A phase IV, multicenter, prospective, 4-week non-inferiority trial

AU - Oh, Pyung Chun

AU - Ahn, Taehoon

AU - Kim, Dong Woon

AU - Hong, Bum Kee

AU - Kim, Dong Soo

AU - Kwan, Jun

AU - Choi, Cheol Ung

AU - Yang, Yong Mo

AU - Bae, Jang Ho

AU - Jung, Kyung Tae

AU - Choi, Woong Gil

AU - Jeon, Dong Woon

AU - Cho, Deok Kyu

AU - Pyun, Wook Bum

AU - Cha, Kwang Soo

AU - Cha, Tae Joon

AU - Chun, Kook Jin

AU - Kim, Young Dae

AU - Kim, Byung Soo

AU - Kim, Doo Il

AU - Kim, Tae Ik

PY - 2016/1/1

Y1 - 2016/1/1

N2 - 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.

AB - 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.

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KW - Clopidogrel

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