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

Study Overview
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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.

Official Title
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COMbination of Clopidogrel and Aspirin for Prevention of REcurrence in Acute Atherothrombotic Stroke Study: Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial

Conditions
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Stroke

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Clopidogrel placebo
* Drug: Aspirin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination therapy<br>Administration of Aspirin + Clopidogrel for 30 days | Drug: Clopidogrel<br>* 75mg tablet, oral administration once daily<br>* Other names: Plavix®;Drug: Aspirin<br>* 100mg tablet, oral administration once daily<br>|
| Active Comparator: Monotherapy<br>Administration of Aspirin + Clopidogrel placebo for 30 days | Drug: Clopidogrel placebo<br>* Matching tablet, oral administration once daily<br>Drug: Aspirin<br>* 100mg tablet, oral administration once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke |  | Within 30 days following the onset of acute atherothrombotic stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of Modified Rankin Scale (mRS) scores |  | Day 30 after the onset of acute atherothrombotic stroke | 
| Number of participants with non-fatal stroke, myocardial infarction (MI) or cardiovascular death (composite endpoint, first-ever) |  | Within 30 days following the onset of acute atherothrombotic stroke | 
| Number of participants with stroke (all kinds) |  | Within 30 days following the onset of acute atherothrombotic stroke | 
| Number of participants with bleeding episode (major or minor) |  | Within 30 days following the onset of acute atherothrombotic stroke | 
| Number of participants with symptomatic intracerebral hemorrhage (ICH) |  | Within 30 days following the onset of acute atherothrombotic stroke |