Stroke
Conditions
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.
Interventions
DRUGClopidogrel
75mg tablet, oral administration once daily
Matching tablet, oral administration once daily
DRUGAspirin
100mg tablet, oral administration once daily
Sponsors
Bristol-Myers Squibb
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed