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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00814268
First received: December 23, 2008
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.

Condition Intervention Phase
Stroke
Drug: Clopidogrel
Drug: Clopidogrel placebo
Drug: Aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: COMbination of Clopidogrel and Aspirin for Prevention of REcurrence in Acute Atherothrombotic Stroke Study: Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distribution of Modified Rankin Scale (mRS) scores [ Time Frame: Day 30 after the onset of acute atherothrombotic stroke ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of participants with stroke (all kinds) [ Time Frame: Within 30 days following the onset of acute atherothrombotic stroke ] [ Designated as safety issue: No ]
  • Number of participants with bleeding episode (major or minor) [ Time Frame: Within 30 days following the onset of acute atherothrombotic stroke ] [ Designated as safety issue: No ]
  • Number of participants with symptomatic intracerebral hemorrhage (ICH) [ Time Frame: Within 30 days following the onset of acute atherothrombotic stroke ] [ Designated as safety issue: No ]

Enrollment: 358
Study Start Date: December 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination therapy
Administration of Aspirin + Clopidogrel for 30 days
Drug: Clopidogrel
75mg tablet, oral administration once daily
Other Name: Plavix®
Drug: Aspirin
100mg tablet, oral administration once daily
Active Comparator: Monotherapy
Administration of Aspirin + Clopidogrel placebo for 30 days
Drug: Clopidogrel placebo
Matching tablet, oral administration once daily
Drug: Aspirin
100mg tablet, oral administration once daily

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814268

Locations
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Director: Hyang Rim Kim Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00814268     History of Changes
Other Study ID Numbers: CLOPI_L_02452
Study First Received: December 23, 2008
Last Updated: February 27, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Recurrence
Stroke
Cerebral Infarction
Disease Attributes
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 18, 2014