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

Stroke Clinical Trial

— COMPRESS  

Official title:

COMbination of Clopidogrel and Aspirin for Prevention of REcurrence in Acute Atherothrombotic Stroke Study: Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814268
• Other study ID #: CLOPI_L_02452
• Status: Completed
• Phase: Phase 4
• First received: December 23, 2008
• Last updated: February 27, 2014
• Start date: December 2008
• Est. completion date: May 2012

Study information

• Verified date: February 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Clopidogrel
75mg tablet, oral administration once daily
• Clopidogrel placebo
Matching tablet, oral administration once daily
• Aspirin
100mg tablet, oral administration once daily

Locations

Country	Name	City	State
Korea, Republic of	Sanofi-Aventis Administrative Office	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke		Within 30 days following the onset of acute atherothrombotic stroke	No
Secondary	Distribution of Modified Rankin Scale (mRS) scores		Day 30 after the onset of acute atherothrombotic stroke	No
Secondary	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	No
Secondary	Number of participants with stroke (all kinds)		Within 30 days following the onset of acute atherothrombotic stroke	No
Secondary	Number of participants with bleeding episode (major or minor)		Within 30 days following the onset of acute atherothrombotic stroke	No
Secondary	Number of participants with symptomatic intracerebral hemorrhage (ICH)		Within 30 days following the onset of acute atherothrombotic stroke	No