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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Stroke

Treatments: Drug: Clopidogrel placebo; Drug: Aspirin; Drug: Clopidogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00814268

CLOPI_L_02452

Details and patient eligibility

About

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.

Enrollment: 358 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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358 participants in 2 patient groups

Combination therapy

Experimental group

Description:

Administration of Aspirin + Clopidogrel for 30 days

Treatment:

Drug: Clopidogrel

Drug: Aspirin

Monotherapy

Active Comparator group

Description:

Administration of Aspirin + Clopidogrel placebo for 30 days

Treatment:

Drug: Aspirin

Drug: Clopidogrel placebo