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

Phase 3

Terminated

• Conditions: Stable Angina Pectoris; Ad Hoc Percutaneous Coronary Intervention
• Interventions: Drug: clopidogrel plus placebo; Drug: clopidogrel

• Registration Number: NCT00638326
• Lead Sponsor: University of Pecs

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-19
• Primary Completion: 2009-09
• Status Verified: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-03-20
• Last Update Posted: 2010-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 500

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	clopidogrel plus placebo	Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel
2	clopidogrel	Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days

Primary Outcome Measures

Name	Time	Method
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation.	12 months

Secondary Outcome Measures

Name	Time	Method
Academic Research Consortium (ARC) definite / probable stent thrombosis	12 months
Cardiac death and non-fatal myocardial infarction	12 months
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding	12 months
5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer	25 +/-2 days
VASP-PRI	25 +/-2 days

Trial Locations

Locations (1)

Heart Institute, University of Pécs, Dept. of Interventional Cardiology; 🇭🇺 Pécs, Hungary