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

Completed

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Aspirin (acute stroke) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: 75mg tablet, oral administration once daily
    ARM 1: Kind: Experimental
    Label: 1
    Description: Administration of combination therapy of Aspirin + Clopidogrel
    ARM 2: Kind: Experimental
    Label: Combination therapy
    Description: Administration of Aspirin + Clopidogrel for 30 days
  • Aspirin Drug
    Other Names: Aspirin at bedtime
    Intervention Desc: 100mg tablet, oral administration once daily
    ARM 1: Kind: Experimental
    Label: 1
    Description: Administration of combination therapy of Aspirin + Clopidogrel
    ARM 2: Kind: Experimental
    Label: 2
    Description: Administration of monotherapy of Aspirin + Clopidogrel placebo
    ARM 3: Kind: Experimental
    Label: Combination therapy
    Description: Administration of Aspirin + Clopidogrel for 30 days
    ARM 4: Kind: Experimental
    Label: Monotherapy
    Description: Administration of Aspirin + Clopidogrel placebo for 30 days
  • Clopidogrel placebo Drug
    Intervention Desc: Matching tablet, oral administration once daily
    ARM 1: Kind: Experimental
    Label: 2
    Description: Administration of monotherapy of Aspirin + Clopidogrel placebo
    ARM 2: Kind: Experimental
    Label: Monotherapy
    Description: Administration of Aspirin + Clopidogrel placebo for 30 days

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patient will be randomized to one of two arms: Experimental Administration of combination therapy of Aspirin + Clopidogrel (Clopidogrel 75mg 1 time a day for 30 days plus Aspirin 100mg 1 time a day for 30 days) or the Active Comparator with monotherapy of Aspirin + Clopidogrel placebo (Clopidogrel placebo 1 time a day for 30 days plus Aspirin 100mg 1 time a day for 30 days). Patient will be followed starting at 30 days with mRS scores.

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of patients with new lesions after the onset of acute atherothrombotic stroke.
Secondary Distribution of mRS scores; nonfatal stroke, MI and vascular death (composite, first-ever); all kind of stroke; number of patients with bleeding episode (major and minor) during the follow-up period; number of patients with symptomatic intracerebral hemorrhage (ICH).
Secondary Distribution of mRS scores 30 days after the onset of stroke throughout the study period No
Secondary Nonfatal stroke, MI and vascular death (composite, first-ever) Throughout the study period No
Secondary All kind of stroke Throughout the study period No
Secondary Number of patients with bleeding episode (major and minor) during the follow-up period Throughout the study period No
Secondary Number of patients with symptomatic intracerebral hemorrhage (ICH) Throughout the study period No
Primary Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke Within 30 days following the onset of acute atherothrombotic stroke No
Secondary Distribution of Modified Rankin Scale (mRS) scores Day 30 after the onset of acute atherothrombotic stroke No
Secondary Number of participants with non-fatal stroke, myocardial infarction (MI) or cardiovascular death (composite endpoint, first-ever) Within 30 days following the onset of acute atherothrombotic stroke No
Secondary Number of participants with stroke (all kinds) Within 30 days following the onset of acute atherothrombotic stroke No
Secondary Number of participants with bleeding episode (major or minor) Within 30 days following the onset of acute atherothrombotic stroke No
Secondary Number of participants with symptomatic intracerebral hemorrhage (ICH) Within 30 days following the onset of acute atherothrombotic stroke No

Sponsors