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

Completed

Phase 4 Results N/A

Update History

1 Mar '14
The Summary of Purpose was updated.
New
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.
Old
Primary objective: - Comparison of efficacy of the combination therapy (clopidogrel plus aspirin) and the aspirin alone (main comparison) to prevent any recurrent ischemic lesion on either 5-day diffusion-weighted (DWI) or 30-day DWI/FLAIR. Secondary objectives: - Comparison of efficacy by using Modified Rankin scale (mRS), all kind of stroke and vascular death - Evaluating the number of patients with bleeding episode (major and minor) and symptomatic intracerebral hemorrhage during the follow-up period.
The eligibility criteria were updated.
New
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.
Old
Inclusion Criteria: - Cerebral ischemic stroke patient identified on DWI within 48 hours from symptom onset - Relevant cerebral atherosclerosis on magnetic resonance angiography (MRA) - 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.
24 May '12
A location was updated in Seoul.
New
The overall status was removed for Sanofi-Aventis Administrative Office.