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

NCT00638326 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2010-03-23

No results posted yet for this study

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.

Conditions

  • Stable Angina Pectoris
  • Ad Hoc Percutaneous Coronary Intervention

Interventions

DRUG

clopidogrel

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

DRUG

clopidogrel plus placebo

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

Sponsors & Collaborators

  • University of Pecs

    lead OTHER

Principal Investigators

  • Ivan G Horvath, MD PhD · Heart Institute, University of Pécs, HUNGARY

  • Daniel Aradi, MD · Heart Institute, University of Pécs, HUNGARY

  • Andras Komocsi, MD PhD · Heart Institute, University of Pécs, HUNGARY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-09-30
Completion
2010-03-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00638326 on ClinicalTrials.gov