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OpenTrials
Completed

NCT Number: NCT00814268

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

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clopidogrel

Drug

75mg tablet, oral administration once daily

Other names: Plavix®

clopidogrel placebo

Drug

Matching tablet, oral administration once daily

Aspirin

Drug

100mg tablet, oral administration once daily

Primary outcomes

  1. 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 outcomes

  1. Distribution of Modified Rankin Scale (mRS) scores

    Time frame: Day 30 after the onset of acute atherothrombotic stroke

  2. 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

  3. Number of participants with stroke (all kinds)

    Time frame: Within 30 days following the onset of acute atherothrombotic stroke

  4. Number of participants with bleeding episode (major or minor)

    Time frame: Within 30 days following the onset of acute atherothrombotic stroke

  5. Number of participants with symptomatic intracerebral hemorrhage (ICH)

    Time frame: Within 30 days following the onset of acute atherothrombotic stroke

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Acronym: COMPRESS

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 24, 2008
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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