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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clopidogrel
Clopidogrel placebo
Aspirin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination therapy

Monotherapy

Arm Description

Administration of Aspirin + Clopidogrel for 30 days

Administration of Aspirin + Clopidogrel placebo for 30 days

Outcomes

Primary Outcome Measures

Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke

Secondary Outcome Measures

Distribution of Modified Rankin Scale (mRS) scores
Number of participants with non-fatal stroke, myocardial infarction (MI) or cardiovascular death (composite endpoint, first-ever)
Number of participants with stroke (all kinds)
Number of participants with bleeding episode (major or minor)
Number of participants with symptomatic intracerebral hemorrhage (ICH)

Full Information

First Posted
December 23, 2008
Last Updated
February 27, 2014
Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00814268
Brief Title
COMbination of Clopidogrel and Aspirin for Prevention of Early REcurrence in Acute Atherothrombotic Stroke
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
358 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination therapy
Arm Type
Experimental
Arm Description
Administration of Aspirin + Clopidogrel for 30 days
Arm Title
Monotherapy
Arm Type
Active Comparator
Arm Description
Administration of Aspirin + Clopidogrel placebo for 30 days
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix®
Intervention Description
75mg tablet, oral administration once daily
Intervention Type
Drug
Intervention Name(s)
Clopidogrel placebo
Intervention Description
Matching tablet, oral administration once daily
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
100mg tablet, oral administration once daily
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Distribution of Modified Rankin Scale (mRS) scores
Time Frame
Day 30 after the onset of acute atherothrombotic stroke
Title
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
Title
Number of participants with stroke (all kinds)
Time Frame
Within 30 days following the onset of acute atherothrombotic stroke
Title
Number of participants with bleeding episode (major or minor)
Time Frame
Within 30 days following the onset of acute atherothrombotic stroke
Title
Number of participants with symptomatic intracerebral hemorrhage (ICH)
Time Frame
Within 30 days following the onset of acute atherothrombotic stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyang Rim Kim
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27418597
Citation
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.
Results Reference
derived

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

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