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Systematic review and meta-analysis

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

cardiovascular prevention - antioxydants - all type of patients


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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antioxydants
  • All clinical trials of succinobucol
    		•  

    ARISE study, 2008

    [NCT00066898] download pdf: succinobucol | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment succinobucol 300 mg once daily
    Control treatment placebo

    Patients

    Patients patients with recent (14-365 days) acute coronary syndromes already managed with conventional treatments
    Inclusion criteria men and women (not of childbearing potential);18 years or older and have diabetes; or 60 years or older, or be 55 years or older and at least one of the following risk factors: low HDL cholesterol (
    Exclusion criteria recent coronary revascularisation (percutaneous coronary intervention

    Method and design

    Randomized effectives 3078 / 3066 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 24 mo (range 12-36 mo)
    Number of centre 261
    Geographic area Canada, US, UK, South Africa
    Hypothesis Superiority
    Primary endpoint CV death, MI, Stroke, UA, revasc


    Results

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

    cardiovascular events

    530 / 3078
         529 / 3066
         1,00 [0,89;1,11]

    new-onset atrial fibrillation

    107 / 2818
         55 / 2787
         classic 1,92 [1,40;2,65]

    cardiovascular death, MI, stroke

    207 / 3078
         252 / 3066
         0,82 [0,69;0,98]

    new-onset diabetes

    30 / 1923
         82 / 1950
         0,37 [0,25;0,56]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    cardiovascular death, MI, stroke 207 / 3078 (6,7%) 252 / 3066 (8,2%) 0,82 [0,69;0,98] CV death, MI, stroke, cardiac arrest 
    new-onset diabetes 30 / 1923 (1,6%) 82 / 1950 (4,2%) 0,37 [0,25;0,56]  
    cardiovascular events 530 / 3078 (17,2%) 529 / 3066 (17,3%) 1,00 [0,89;1,11] primary endpoint 
    new-onset atrial fibrillation 107 / 2818 (3,8%) 55 / 2787 (2,0%) 1,92 [1,40;2,65]  
    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, MI, stroke 6,73% 8,22% -14,9‰
    new-onset diabetes 1,56% 4,21% -26,5‰
    cardiovascular events 17,22% 17,25% -0,3‰
    new-onset atrial fibrillation 3,80% 1,97% 1,8%

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for all type of patients



    Reference(s)

    Trials register # NCT00066898
    • Tardif JC, McMurray JJ, Klug E, Small R, Schumi J, Choi J, Cooper J, Scott R, Lewis EF, L'Allier PL, Pfeffer MA. Effects of succinobucol (AGI-1067) after an acute coronary syndrome: a randomised, double-blind, placebo-controlled trial.. Lancet 2008;371:1761-8
      Pubmed | Hubmed | Fulltext

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