Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-12-31

Brief Summary

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The primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral infarction with respect to incidence of bleeding adverse events.

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Detailed Description

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Conditions

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Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

50 mg

Group Type EXPERIMENTAL

clopidogrel (SR25990C)

Intervention Type DRUG

oral administration

2

75 mg

Group Type EXPERIMENTAL

clopidogrel (SR25990C)

Intervention Type DRUG

oral administration

Interventions

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clopidogrel (SR25990C)

oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with an episode of cerebral infarction (excluding cardiogenic cerebral thromboembolism) occurring at least 8 days prior to randomization and for whom the clinical course up to randomization is well-documented
* Patients with a cerebral infarct confirmed by Computed Tomography or Magnetic Resonance Image
* Body weight : \> 50 kg

Exclusion Criteria

* Patients with cardiogenic cerebral thromboembolism or disease that could precipitate cardiogenic cerebral thromboembolism, such as atrial fibrillation or valvular hear disease (including valve replacement)
* Patients with Transient Ischemic Attack occuring after the last episode of cerebral infarction
* Patients with serious impairment that would hinder detection of new ischemic event
* Patients with bleeding diathesis, coagulopathy, or hemorrhagic disease
* Patients with history of intracranial hemorrhage
* Patients with diabetic retinopathy
* Hypertensive patients with a persistent increase of blood pressure.

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No