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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 (<1·03 mmol/L in men and <1·30 mmol/L in women); a myocardial infarction before the qualifying event; evidence of additional atherosclerosis in a non-coronary arterial bed (eg, prior stroke, presence of peripheral arterial disease); or prior evidence of heart failure or left ventricular ejection fraction less than 40%
    Exclusion criteria recent coronary revascularisation (percutaneous coronary intervention <28 days and coronary artery bypass graft surgery <90 days before randomisation), moderate or severe symptomatic heart failure, systolic blood pressure above 180 mm Hg, serum creatinine of 221 ìmol/L or greater, concentrations of alanine or aspartate aminotransferases greater than twice the upper limit of normal, use of medications known to increase the QT interval by 15 ms or more, or comorbidity with survival expected to be less than 2 years

    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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