Optimization of Antiplatelet Therapy With Clopidogrel on the Basis of the Extent of Platelet Inhibition in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy Undergoing PCI With Stent Implantation
Overview
- Phase
- Phase 3
- Intervention
- comparison of different dosage of clopidogrel
- Conditions
- Unstable Angina
- Sponsor
- University of Florence
- Enrollment
- 442
- Locations
- 1
- Primary Endpoint
- Incidence of MACE (cardiovascular death, nonfatal myocardial infarction, target lesion vessel revascularization by PCI or coronary bypass)
- Last Updated
- 17 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy (reduction of major ischemic events at 6 and 12 months of follow-up) of a tailored clopidogrel therapy in patients with UA/NSTEMI undergoing PCI with stent implantation and wiht a documented residual platelet reactivity assessed by a point of care system (VerifyNow P2Y12).
Detailed Description
Several studies documented the presence of a high variability in the individual response to antiplatelet therapies in terms of extent of platelet function inhibition. This laboratory finding is the so-called aspirin or clopidogrel resistance which we prefer to define residual platelet reactivity (RPR) on antiplatelet therapy. A growing body of evidence is demonstrating the clinical relevance of this laboratory parameter, i.e. patients with RPR are at higher risk of a subsequent adverse cardiovascular event. In particular, it has been demonstrated that RPR measured by light transmittance aggregometry induced by ADP or by the point of care assay VerifyNow P2Y12 identifies patients which, after coronary revascularization with stent implantation, at higher risk of a potentially catastrophic event such as stent thrombosis. No randomized trials are available in the literature on the efficacy and safety of an antiplatelet therapy tailored on the extent of platelet function inhibition.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Unstable or NSTEMI
Exclusion Criteria
- •Previous bleeding events which have required blood transfusion
- •PT- INR \>1.5
- •Platelet count ≤ 100000/ mm3
- •Hb \< 10 g/dl
- •Previous TIA/stroke (ischemic or hemorrhagic or unknown)
- •Body weight \< 60 Kg
- •Creatinine levels ≥ 4 mg/dl
- •Cerebral neoplasia
- •Recent major trauma/surgery/head injury (within 3 previous weeks)
- •Gastrointestinal hemorrhage in the last month
Arms & Interventions
1: standard therapy
clopidogrel 75 mg/day
Intervention: comparison of different dosage of clopidogrel
2: doubled therapy
clopidogrel 150 mg/day
Intervention: doubled therapy
Outcomes
Primary Outcomes
Incidence of MACE (cardiovascular death, nonfatal myocardial infarction, target lesion vessel revascularization by PCI or coronary bypass)
Time Frame: 6 and 12 months
Secondary Outcomes
- Stent thrombosis with angiographic confirmation; platelet function assessed by VerifyNow P2Y12 1 week after the randomization(1 week; 6 and 12 months)