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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

cardiovascular prevention - antiplatelets drug - all type of patients  


Related trials

AAA, 2009 - aspirin vs placebo

CHARISMA, 2006 - clopidogrel + aspirin vs aspirin

Women�s Health Study, 2005 - aspirin vs placebo

Primary Prevention Project, 2001 - aspirin vs no treatment

HOT, 1998 - aspirin vs placebo

Thrombosis Prevention Trial, 1998 - aspirin vs placebo

CAPRIE, 1996 - clopidogrel vs aspirin

Physicians Health Study, 1989 - aspirin vs placebo

British Doctor�s Trial, 1988 - aspirin vs no treatment



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antiplatelets drug
  • All clinical trials of clopidogrel
    		•  

    CAPRIE study, 1996

    Treatments

    Studied treatment clopidogrel 75 mg once daily
    Control treatment aspirin 325 mg once daily

    Patients

    Patients patients with atherosclerotic vascular disease manifested as either recent ischaemic stroke, recent myocardial infarction, or symptomatic peripheral arterial disease
    Inclusion criteria Ischaemic stroke (including retinal origin and lacunar infarction): Focal neurological deficit likely to be of atherothrombotic; Onset >=1 week and <=6 months before randomisation; Neurological signs persisting >=1 week from stroke onset, CT or MRI ruling out haemorrhage or non-relevant disease Myocardial infarction: Onset <=35 days before randomisation; Two of: Characteristic ischaemic pain for >=20 min, Elevation of CK, CK-MB, LDH, or AST to 2x upper limit of laboratory normal with no other explanation, Development of new >=40 Q waves in at least two adjacent ECG leads or new dominant R wave in V1 (R>=1 mm > S in V1) Atherosclerotic peripheral: Intermittent claudication (WHO: leg pain on walking, arterial disease disappearing in <10 min on standing) of presumed atherosclerotic origin; andankle/arm systolic BP ratio <=0.85 in either leg at rest (two assessments on separate days); or history of intermittent claudication with previous leg amputation, reconstructive surgery, or angioplasty with no persisting complications from intervention
    Exclusion criteria Age <21 years; Severe cerebral deficit likely to lead to patient being bedridden or demented; Carotid endarterectomy after qualifying stroke; Qualifying stroke induced by carotid endarterectomy or angiography; Patient unlikely to be discharged aline after qualifying event; Severe co-morbidity likely to limit patient�s life expectancy to less than 3 y; Uncontrolled hypertension; Scheduled for major surgery; Contraindications to study drugs: Severe renal or hepatic insufficiency, Haemostatic disorder or systemic bleeding, History of haemostatic disorder or systemic bleeding, History of thrombocytopenia or neutropenia, History of drug-induced haematologic or hepatic abnormalities, Known to have abnormal WBC, differential, or platelet count, anticipated requirement for long-term anticoagulants, non-study antiplatelet drugs or NSAIDs affecting platelet function, History of aspirin sensitivity
    Baseline characteristics
    Age (yr) 62.5 (mean) 
    Female (%) 28 
    Documented vascular disease 100% 
    Multiple risk factors 0% 
    Prior myocardial infarction 16.5 
    Prior stroke 9 
    Diabetes 20 
    Peripheral arterial disease 4.5 
    Diabetic nephropathy NA 
    Hypertension 51.5 

    Method and design

    Randomized effectives 9599 / 9586 (studied vs. control)
    Design Parallel groups
    Blinding Double blind
    Follow-up duration mean 1.91 years
    Lost to follow-up 42 (0.22%)
    Number of centre 384
    Geographic area 16 countries
    Hypothesis Superiority
    Primary endpoint ischaemic stroke, myocardial infarction, or vascular death
    Withdrawals (T1/T0) 21.3% / 21.1%


    Results

    Endpoint Studied treat.
    n/N     Control treat.
    n/N     Graph RR [95% CI]

    Cardiovascular death

    350 / 9599
         378 / 9586
         0,92 [0,80;1,07]

    Non fatal stroke

    405 / 9599
         430 / 9586
         0,94 [0,82;1,07]

    cardiovascular event (fatal and non fatal)

    939 / 9599
         1021 / 9586
         0,92 [0,84;1,00]

    All cause death

    560 / 9599
         571 / 9586
         0,98 [0,87;1,10]

    Non fatal MI

    226 / 9599
         270 / 9586
         0,84 [0,70;1,00]

    Major bleeding

    132 / 9599
         149 / 9586
         0,88 [0,70;1,12]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Cardiovascular death 350 / 9599 (3,6%) 378 / 9586 (3,9%) 0,92 [0,80;1,07] vascular death   
    Non fatal stroke 405 / 9599 (4,2%) 430 / 9586 (4,5%) 0,94 [0,82;1,07]    
    All cause death 560 / 9599 (5,8%) 571 / 9586 (6,0%) 0,98 [0,87;1,10]    
    Non fatal MI 226 / 9599 (2,4%) 270 / 9586 (2,8%) 0,84 [0,70;1,00]    
    Major bleeding 132 / 9599 (1,4%) 149 / 9586 (1,6%) 0,88 [0,70;1,12]    
    cardiovascular event (fatal and non fatal) 939 / 9599 (9,8%) 1021 / 9586 (10,7%) 0,92 [0,84;1,00]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Cardiovascular death 3,65% 3,94% -3,0‰
    Non fatal stroke 4,22% 4,49% -2,7‰
    All cause death 5,83% 5,96% -1,2‰
    Non fatal MI 2,35% 2,82% -4,6‰
    Major bleeding 1,38% 1,55% -1,8‰
    cardiovascular event (fatal and non fatal) 9,78% 10,65% -8,7‰


    Reference(s)

    Trials register # NA
    • . A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee.. Lancet 1996 Nov 16;348:1329-39
      Pubmed | Hubmed | Fulltext

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