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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Bristol-Myers Squibb
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

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.