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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: May 22, 2012
Last verified: May 2012
History of Changes
  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 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.

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)
Primary Purpose: Treatment
Official Title: COMbination of Clopidogrel and Aspirin for Prevention of Early REcurrence in Acute Atherothrombotic Stroke

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patients with new lesions after the onset of acute atherothrombotic stroke. [ Time Frame: 5 or 30 day DWI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distribution of mRS scores [ Time Frame: 30 days after the onset of stroke throughout the study period ] [ Designated as safety issue: No ]
  • Nonfatal stroke, MI and vascular death (composite, first-ever) [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • All kind of stroke [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Number of patients with bleeding episode (major and minor) during the follow-up period [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Number of patients with symptomatic intracerebral hemorrhage (ICH) [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]

Enrollment: 359
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: 1
Administration of combination therapy of Aspirin + Clopidogrel
 Drug: Clopidogrel
75mg 1 time a day for 30 days
Drug: Aspirin
100mg 1 time a day for 30 days
Active Comparator: 2
Administration of monotherapy of Aspirin + Clopidogrel placebo
 Drug: Clopidogrel placebo
1 time a day for 30 days
Drug: Aspirin
100mg 1 time a day for 30 days

  Eligibility

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

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.

  Contacts and Locations
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: May 22, 2012
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 May 19, 2013