+ Site Statistics
+ Search Articles
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ PDF Full Text
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Translate
+ Recently Requested

Antiplatelet Efficacy of Fixed-Dose Aspirin-Clopidogrel Combination in Patients with Stable Coronary Artery Disease Treated with Drug-Eluting Stent Implantation

Antiplatelet Efficacy of Fixed-Dose Aspirin-Clopidogrel Combination in Patients with Stable Coronary Artery Disease Treated with Drug-Eluting Stent Implantation

Clinical Drug Investigation 35(12): 833-842

A fixed-dose combination (FDC) of aspirin and clopidogrel bisulfate may improve medication adherence. However, the absence of data on the relative antiplatelet efficacy of FDC and separate dual pills (SDP) of aspirin and clopidogrel in real-world patients with stable coronary artery disease is a major factor retarding clinical introduction of such an FDC. This was a single-centre, randomized, open-label, parallel-group, non-inferiority trial. Patients who maintained a regimen of separate aspirin and clopidogrel pills for at least 1 year after drug-eluting stent implantation without adverse events were enrolled. Patients were randomly assigned to either the FDC group or the SDP group. Antiplatelet efficacy and tolerability were assessed at baseline and at 4 weeks. Of the 93 enrolled patients, 83 (FDC group: n = 42; SDP group: n = 41) completed the study. The difference in the changes in P2Y12 percentage inhibition did not exceed the predetermined value for inferiority [mean difference -1.7; 95 % confidence interval (CI) -6.9 to 4.5, p < 0.001 for non-inferiority]. The changes from baseline to 4 weeks in P2Y12 reaction units (PRU) (mean difference 9.7 PRU, p = 0.46), maximal platelet aggregation (mean difference 2.0 %, p = 0.44) and aspirin reaction units (ARU) (mean difference -2.3 ARU, p = 0.88) did not differ significantly between the treatment groups. The tolerability of the FDC formulation was similar to that of SDP therapy (p = 0.68). In patients with prior percutaneous coronary intervention, the antiplatelet efficacy of the aspirin/clopidogrel FDC was non-inferior to that of SDP and the tolerability of the two regimens was similar after 4 weeks of treatment.

(PDF emailed within 0-6 h: $19.90)

Accession: 057215899

Download citation: RISBibTeXText

PMID: 26507618

DOI: 10.1007/s40261-015-0350-2

Related references

Efficacy and safety of low-dose clopidogrel after 12-month dual antiplatelet therapy for patients having drug-eluting stent implantation. Journal of Thoracic Disease 6(5): 459-465, 2014

A randomized clinical trial comparing long-term clopidogrel vs aspirin monotherapy beyond dual antiplatelet therapy after drug-eluting coronary stent implantation: Design and rationale of the Harmonizing Optimal Strategy for Treatment of coronary artery stenosis-Extended Antiplatelet Monotherapy (HOST-EXAM) trial. American Heart Journal 185: 17-25, 2017

Routine assessment of on-clopidogrel platelet reactivity and gene polymorphisms in predicting clinical outcome following drug-eluting stent implantation in patients with stable coronary artery disease. Jacc. Cardiovascular Interventions 6(11): 1166-1175, 2014

Efficacy and safety of concomitant use of rabeprazole during dual-antiplatelet therapy with clopidogrel and aspirin after drug-eluting stent implantation: a retrospective cohort study. Yakugaku Zasshi 130(12): 1743-1750, 2011

Comparison of 1-Year Outcomes of Triple (Aspirin + Clopidogrel + Cilostazol) Versus Dual Antiplatelet Therapy (Aspirin + Clopidogrel + Placebo) After Implantation of Second-Generation Drug-Eluting Stents into One or More Coronary Arteries: from the DECREASE-PCI Trial. American Journal of Cardiology: -, 2017

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. Platelets (): 1-7, 2016

Soluble CD40 ligand release in patients with stable coronary artery disease during elective stent implantation: effect of drug-eluting stent over bare metal stent. Turk Kardiyoloji Dernegi Arsivi 41(8): 675-682, 2015

Impact of different proton pump inhibitors on the antiplatelet activity of clopidogrel in combination with aspirin for patients undergoing coronary stent implantation. Zhongguo Ying Yong Sheng Li Xue Za Zhi 26(3): 266-269, 2012

Temporal variability in the antiplatelet effects of clopidogrel and aspirin after elective drug-eluting stent implantation. An ADAPT-DES substudy. Thrombosis and Haemostasis 114(5): 1020-1027, 2016

Combination antiplatelet therapy with aspirin plus clopidogrel versus aspirin plus ticlopidine for prevention of subacute thrombosis after native coronary stent implantation. Circulation 100(18 SUPPL ): I 379, Nov 2, 1999

Novel Biomarkers for Coronary Restenosis Occurrence After Drug-Eluting Stent Implantation in Patients With Diabetes Having Stable Coronary Artery Disease. Clinical and Applied Thrombosis/Hemostasis 24(8): 1308-1314, 2018

Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease: results of the CILON-T (influence of CILostazol-based triple antiplatelet therapy ON ischemic complication after drug-eluting stenT implantation) trial. Journal of the American College of Cardiology 57(3): 280-289, 2011

Risk factors of cardiac troponin T elevation in patients with stable coronary artery disease after elective coronary drug-eluting stent implantation. Clinical Cardiology 34(12): 768-773, 2012

Adjunctive cilostazol versus double-dose clopidogrel after drug-eluting stent implantation: the HOST-ASSURE randomized trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Safety & Effectiveness of Drug-Eluting Stents & Anti-platelet Regimen). Jacc. Cardiovascular Interventions 6(9): 932-942, 2014

Prognostic value of plasma pentraxin-3 levels in patients with stable coronary artery disease after drug-eluting stent implantation. Mediators of Inflammation 2014: 963096-963096, 2015