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

February 27, 2014 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

358

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination therapy
Administration of Aspirin + Clopidogrel for 30 days
Drug: Clopidogrel
75mg tablet, oral administration once daily
Other Names:
  • Plavix®
Drug: Aspirin
100mg tablet, oral administration once daily
Active Comparator: Monotherapy
Administration of Aspirin + Clopidogrel placebo for 30 days
Drug: Aspirin
100mg tablet, oral administration once daily
Drug: Clopidogrel placebo
Matching tablet, oral administration once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke
Time Frame: Within 30 days following the onset of acute atherothrombotic stroke
Within 30 days following the onset of acute atherothrombotic stroke

Secondary Outcome Measures

Outcome Measure
Time Frame
Distribution of Modified Rankin Scale (mRS) scores
Time Frame: Day 30 after the onset of acute atherothrombotic stroke
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)
Time Frame: Within 30 days following the onset of acute atherothrombotic stroke
Within 30 days following the onset of acute atherothrombotic stroke
Number of participants with stroke (all kinds)
Time Frame: Within 30 days following the onset of acute atherothrombotic stroke
Within 30 days following the onset of acute atherothrombotic stroke
Number of participants with bleeding episode (major or minor)
Time Frame: Within 30 days following the onset of acute atherothrombotic stroke
Within 30 days following the onset of acute atherothrombotic stroke
Number of participants with symptomatic intracerebral hemorrhage (ICH)
Time Frame: Within 30 days following the onset of acute atherothrombotic stroke
Within 30 days following the onset of acute atherothrombotic stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Hyang Rim Kim, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 23, 2008

First Submitted That Met QC Criteria

December 23, 2008

First Posted (Estimate)

December 24, 2008

Study Record Updates

Last Update Posted (Estimate)

February 28, 2014

Last Update Submitted That Met QC Criteria

February 27, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOPI_L_02452

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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