COMbination of Clopidogrel and Aspirin for Prevention of Early REcurrence in Acute Atherothrombotic Stroke

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

358 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-05-31

Brief Summary

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Primary objective:

* Comparison of efficacy of the combination therapy (clopidogrel plus aspirin) and the aspirin alone (main comparison) to prevent any recurrent ischemic lesion .

Secondary objectives:

* Comparison of Modified Rankin scale (mRS) scores;
* Comparison of the Incidence of all kinds of stroke and vascular death;
* Comparison of the Incidence of bleeding episodes (major and minor) and symptomatic intracerebral hemorrhages during the follow-up period.

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Combination therapy

Administration of Aspirin + Clopidogrel for 30 days

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

75mg tablet, oral administration once daily

Aspirin

Intervention Type DRUG

100mg tablet, oral administration once daily

Monotherapy

Administration of Aspirin + Clopidogrel placebo for 30 days

Group Type ACTIVE_COMPARATOR

Clopidogrel placebo

Intervention Type DRUG

Matching tablet, oral administration once daily

Aspirin

Intervention Type DRUG

100mg tablet, oral administration once daily

Interventions

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Clopidogrel

75mg tablet, oral administration once daily

Intervention Type DRUG

Clopidogrel placebo

Matching tablet, oral administration once daily

Intervention Type DRUG

Aspirin

100mg tablet, oral administration once daily

Intervention Type DRUG

Other Intervention Names

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Plavix®

Eligibility Criteria

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Inclusion Criteria

* Ischemic stroke diagnosed within 48 hours from symptom onset;
* Cerebral ischemic lesion observed on diffusion-weighted magnetic resonance imaging (DWI MRI);
* Relevant atherothrombotic lesions on magnetic resonance angiography (MRA) or computed tomography angiography (CTA);
* Study drug administration within 48 hours from symptom onset;
* mRS score is 0-2 before the stroke.

Exclusion Criteria

* Evidences of other relevant brain lesions such as Intracerebral hemorrhage (ICH) or brain tumor;
* Suspicious of stroke due to small-vessel occlusion;
* Stroke due to cardioembolism;
* Clinical necessity of conventional angiography or intervention before the end of study;
* Past history of ICH;
* Bleeding diathesis or coagulopathy;
* Chronic anemia (Hb\<8.0) or thrombocytopenia (PLT\<100K);
* Chronic liver disease (AST\> 100 or ALT\>100);
* Any other clinically relevant serious disease, including renal failure ( creatinine clearance\<30mL/min);
* Allergy to Aspirin or clopidogrel;
* Subjected to intervention or surgical treatments within 3 months;
* Thrombolysis performed with rt-PA or UK after the stroke;
* Participation in another clinical study within the previous 30 days;
* Suspicious of poor drug compliance and requirements of the protocol;
* Females who are pregnant, breast-feeding, or childbearing potential and not using medically acceptable and effective contraception.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No