Key result
A fixed-dose clopidogrel-aspirin combination (HCP0911) was noninferior to separate administration for P2Y12 Reaction Units (mean difference -5; 90% CI -23 to 13; P=0.015 for noninferiority).
Why the study?
Does a fixed-dose combination of clopidogrel and aspirin provide non-inferior antiplatelet effects compared to separate administration in stented patients?
RCT (n=30)
Open-label
randomized
Does a fixed-dose combination of clopidogrel and aspirin provide non-inferior antiplatelet effects compared to separate administration in stented patients?
Mean Difference: -5 (95% CI -23–13)
Absolute Event Rate: 202% vs 207%
p-value: p=0.015 for non-inferiority
A fixed-dose combination of clopidogrel and aspirin provides non-inferior antiplatelet effects compared to separate pills, offering a convenient option to potentially improve adherence in stented patients.
Supports fixed-dose clopidogrel-aspirin in stented patients; confirms non-inferior antiplatelet efficacy and extends adherence options.
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.
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Koh et al. (2016) conducted an RCT in Patients with coronary stents (n=30). HCP0911 (fixed-dose clopidogrel-aspirin combination) vs. Separate treatment with daily 75 mg clopidogrel plus 100 mg aspirin was evaluated on P2Y12 Reaction Units (PRU) measured by VerifyNow (MD -5, 95% CI -23 to 13, p=0.015 for non-inferiority). A fixed-dose clopidogrel-aspirin combination (HCP0911) was noninferior to separate administration for P2Y12 Reaction Units (mean difference -5; 90% CI -23 to 13; P=0.015 for noninferiority).
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