Doubling the Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity

Phase 3TerminatedNCT00638326

University of Pecs500 enrolled

Overview

The 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

500

Conditions

Stable Angina Pectoris Ad Hoc Percutaneous Coronary Intervention

Interventions

clopidogrelDRUG

150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year

clopidogrel plus placeboDRUG

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

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Heart Institute, University of Pécs, Dept. of Interventional Cardiology

Pécs, Hungary

Outcomes

Primary Outcomes

Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation.

Time frame: 12 months

Secondary Outcomes

Academic Research Consortium (ARC) definite / probable stent thrombosis

Time frame: 12 months

Cardiac death and non-fatal myocardial infarction

Time frame: 12 months

Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding

Time frame: 12 months

5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer

Time frame: 25 +/-2 days

VASP-PRI

Time frame: 25 +/-2 days

Data from ClinicalTrials.gov

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