Status:
COMPLETED
COMbination of Clopidogrel and Aspirin for Prevention of Early REcurrence in Acute Atherothrombotic Stroke
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Stroke
Eligibility:
All Genders
30+ years
Phase:
PHASE4
Brief 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 objecti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT00814268
Start Date
December 1 2008
End Date
May 1 2012
Last Update
February 28 2014
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Seoul, South Korea