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

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ClinicalTrials.gov Identifier: NCT00814268
Recruitment Status : Completed
First Posted : December 24, 2008
Last Update Posted : February 28, 2014
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE December 23, 2008
First Posted Date  ICMJE December 24, 2008
Last Update Posted Date February 28, 2014
Study Start Date  ICMJE December 2008
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 23, 2008)
Number of patients with new lesions after the onset of acute atherothrombotic stroke. [ Time Frame: 5 or 30 day DWI ]
Change History Complete list of historical versions of study NCT00814268 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
  • Distribution of Modified Rankin Scale (mRS) scores [ Time Frame: 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 ]
  • Number of participants with stroke (all kinds) [ Time Frame: 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 ]
  • Number of participants with symptomatic intracerebral hemorrhage (ICH) [ Time Frame: Within 30 days following the onset of acute atherothrombotic stroke ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2008)
  • Distribution of mRS scores [ Time Frame: 30 days after the onset of stroke throughout the study period ]
  • Nonfatal stroke, MI and vascular death (composite, first-ever) [ Time Frame: Throughout the study period ]
  • All kind of stroke [ Time Frame: Throughout the study period ]
  • Number of patients with bleeding episode (major and minor) during the follow-up period [ Time Frame: Throughout the study period ]
  • Number of patients with symptomatic intracerebral hemorrhage (ICH) [ Time Frame: Throughout the study period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COMbination of Clopidogrel and Aspirin for Prevention of Early REcurrence in Acute Atherothrombotic Stroke
Official Title  ICMJE COMbination of Clopidogrel and Aspirin for Prevention of REcurrence in Acute Atherothrombotic Stroke Study: Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Drug: Clopidogrel
    75mg tablet, oral administration once daily
    Other Name: Plavix®
  • Drug: Clopidogrel placebo
    Matching tablet, oral administration once daily
  • Drug: Aspirin
    100mg tablet, oral administration once daily
Study Arms  ICMJE
  • Experimental: Combination therapy
    Administration of Aspirin + Clopidogrel for 30 days
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Active Comparator: Monotherapy
    Administration of Aspirin + Clopidogrel placebo for 30 days
    Interventions:
    • Drug: Clopidogrel placebo
    • Drug: Aspirin
Publications * Hong KS, Lee SH, Kim EG, Cho KH, Chang DI, Rha JH, Bae HJ, Lee KB, Kim DE, Park JM, Kim HY, Cha JK, Yu KH, Lee YS, Lee SJ, Choi JC, Cho YJ, Kwon SU, Kim GM, Sohn SI, Park KY, Kang DW, Sohn CH, Lee J, Yoon BW; COMPRESS Investigators. Recurrent Ischemic Lesions After Acute Atherothrombotic Stroke: Clopidogrel Plus Aspirin Versus Aspirin Alone. Stroke. 2016 Sep;47(9):2323-30. doi: 10.1161/STROKEAHA.115.012293. Epub 2016 Jul 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2014)
358
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2008)
360
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00814268
Other Study ID Numbers  ICMJE CLOPI_L_02452
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Hyang Rim Kim Sanofi
PRS Account Sanofi
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP