Title
Doubling the Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity
150 mg Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity After Elective Percutaneous Coronary Intervention
Phase
Phase 3Lead Sponsor
University of PecsStudy Type
InterventionalStatus
TerminatedIndication/Condition
Stable Angina Pectoris Ad Hoc Percutaneous Coronary InterventionIntervention/Treatment
clopidogrel ...Study Participants
500The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel after elective percutaneous coronary intervention.
150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year
75 mg maintenance dose (one capsule of 75 mg clopidogrel and one capsule placebo) for 28 days followed by standard 75 mg clopidogrel for one year
Patients who show adequate response to 600 mg loading dose of clopidogrel and receive standard 1x75 mg clopidogrel
Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days
Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel
Inclusion Criteria: Clopidogrel-naïve stable angina pectoris (CCS I-III) Coronary angiography that reveals significant DE NOVO coronary stenosis (diameter stenosis greater than 50% in two independent projections) feasible for ad hoc stent implantation Exclusion Criteria: Acute coronary syndrome (STEMI, NSTEMI or unstable angina) Administration of clopidogrel/ticlopidine/coumarin in the past 6 weeks Contraindication to antiplatelet therapy Significant LM stenosis PCI due to instent restenosis Lesion located in bypass grafts Stroke in past one year Reduced life expectancy
