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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stable Angina Pectoris Ad Hoc Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Patients who show adequate response to 600 mg loading dose of clopidogrel and receive standard 1x75 mg clopidogrel

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days

Group Type EXPERIMENTAL

clopidogrel

Intervention Type DRUG

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

3

Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel

Group Type ACTIVE_COMPARATOR

clopidogrel plus placebo

Intervention Type DRUG

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

Interventions

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clopidogrel

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No