COMbination of Clopidogrel and Aspirin for Prevention of Early REcurrence in Acute Atherothrombotic Stroke
Phase 4
Completed
- Conditions
- Stroke
- Interventions
- Registration Number
- NCT00814268
- Lead Sponsor
- Sanofi
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 358
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination therapy Clopidogrel Administration of Aspirin + Clopidogrel for 30 days Combination therapy Aspirin Administration of Aspirin + Clopidogrel for 30 days Monotherapy Clopidogrel placebo Administration of Aspirin + Clopidogrel placebo for 30 days Monotherapy Aspirin Administration of Aspirin + Clopidogrel placebo for 30 days
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇰🇷Seoul, Korea, Republic of