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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 + aspirin
  •  

    CHARISMA study, 2006

    Treatments

    Studied treatment clopidogrel (75 mg per day) plus low-dose aspirin (75 to 162 mg per day)
    Control treatment placebo plus low-dose aspirin

    Patients

    Patients patients with either clinically evident cardiovascular disease or multiple risk factors
    Inclusion criteria multiple atherothrombotic risk factors, documented coronary disease, documented cerebrovascular disease, or documented symptomatic peripheral arterial disease. To meet the criterion for enrollment on the basis of multiple risk factors, patients were required to have two major or three minor or one major and two minor risk factors. Major RF were Type 1 or 2 diabetes (with drug therapy); Diabetic nephropathy; Ankle/brachial index <0.9; Asymptomatic carotid stenosis >70% of luminal diameter; one or more carotid plaque, as evidenced by intima media thickness. Minor RF were Systolic blood pressure >150 mm Hg, despite therapy for at least 3 mo; Primary hypercholesterolemia; Current smoking >15 cigarettes/day; Male sex and age >65 yr or female sex and age >70 yr
    Exclusion criteria age<45y; oral antithrombotic medications or nonsteroidal antiinflammatory drugs on a longterm basis (although cyclooxygenase-2 inhibitors were permitted); established indications for clopidogrel therapy (such as a recent acute coronary syndrome)
    Baseline characteristics
    Age (yr) median 64 (39-95) 
    Female (%) 29.75 
    Documented vascular disease 77.9 
    Multiple risk factors 21.05 
    Prior myocardial infarction 34.55 
    Prior stroke 24.6 
    Diabetes 42 
    Peripheral arterial disease 22.65 
    Diabetic nephropathy 12.9 
    Hypertension 73.95 
    Hypercholesterolemia 73.95 

    Method and design

    Randomized effectives 7802 / 7801 (studied vs. control)
    Design Parallel groups
    Blinding Double blind
    Follow-up duration median 28 months
    Lost to follow-up 0.45%
    Number of centre 768
    Geographic area 32 countries
    Hypothesis Superiority
    Primary endpoint myocardial infarction, stroke or death from cardiovasculare causes
    Withdrawals (T1/T0) 0.3% / 0.3%


    Results

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

    All cause death

    371 / 7802
    374 / 7801
    0,99 [0,86;1,14]

    Non fatal MI

    147 / 7802
    159 / 7801
    0,92 [0,74;1,15]

    Major bleeding

    130 / 7802
    104 / 7801
    1,25 [0,97;1,61]

    cardiovascular event (fatal and non fatal)

    534 / 7802
    573 / 7801
    0,93 [0,83;1,04]

    Cardiovascular death

    238 / 7802
    229 / 7801
    1,04 [0,87;1,24]

    Non fatal stroke

    149 / 7802
    185 / 7801
    0,81 [0,65;1,00]

    Fatal bleeding

    26 / 7802
    17 / 7801
    classic 1,53 [0,83;2,82]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    All cause death 371 / 7802 (4,8%) 374 / 7801 (4,8%) 0,99 [0,86;1,14]    
    Non fatal MI 147 / 7802 (1,9%) 159 / 7801 (2,0%) 0,92 [0,74;1,15]    
    Major bleeding 130 / 7802 (1,7%) 104 / 7801 (1,3%) 1,25 [0,97;1,61]    
    cardiovascular event (fatal and non fatal) 534 / 7802 (6,8%) 573 / 7801 (7,3%) 0,93 [0,83;1,04]    
    Cardiovascular death 238 / 7802 (3,1%) 229 / 7801 (2,9%) 1,04 [0,87;1,24]    
    Non fatal stroke 149 / 7802 (1,9%) 185 / 7801 (2,4%) 0,81 [0,65;1,00]    
    Fatal bleeding 26 / 7802 (0,3%) 17 / 7801 (0,2%) 1,53 [0,83;2,82]    
    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.
    All cause death 4,76% 4,79% -0,4‰
    Non fatal MI 1,88% 2,04% -1,5‰
    Major bleeding 1,67% 1,33% 3,3‰
    cardiovascular event (fatal and non fatal) 6,84% 7,35% -5,0‰
    Cardiovascular death 3,05% 2,94% 1,1‰
    Non fatal stroke 1,91% 2,37% -4,6‰
    Fatal bleeding 3,33‰ 2,18‰ 1,2‰


    Reference(s)

    Trials register # NA
    Study web site link 2
    • . 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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