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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

cardiovascular prevention - antioxydants - secondary prevention


Related trials

POPADAD (antioxydant), 2008 - combination vs placebo

ARISE, 2008 - succinobucol vs placebo

PHS II vitamin E, 2008 - vitamin E vs placebo

PHS II vitamin C, 2008 - vitamin C vs placebo

WACS beta-caroten, 2007 - beta carotene vs placebo

WACS vitamin E, 2007 - vitamin E vs placebo

WACS vitamin C, 2007 - vitamin C vs placebo

SUVIMAX, 2005 - combination vs placebo

WHS vitamin E, 2005 - vitamin E vs placebo

HOPE renal insufficiency subgroup, 2004 - vitamin E vs placebo

PHS II beta carotene, 2003 - combination vs placebo

Tepel, 2003 - acetylcysteine vs placebo

HPS antioxidant, 2002 - combination vs placebo

WAVE (Waters), 2002 - combination vs placebo

HATS, 2001 - combination vs placebo

PPP, 2001 - vitamin E vs control

AREDS, 2001 - vitamin E vs placebo

ASAP, 2000 - vitamin E vs placebo

SPACE, 2000 - vitamin E vs placebo

HOPE, 2000 - vitamin E vs placebo

GISSI, 1999 - vitamin E vs control

NSCP (Green) beta carotene, 1999 - beta carotene vs placebo

WHS beta carotene, 1999 - beta carotene vs placebo

ATBC 2nd prev subgroup (b carotene), 1998 - beta carotene vs placebo

ATBC 2nd prev subgroup (vitamin E), 1998 - vitamin E vs placebo



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antioxydants
  • All clinical trials of vitamin E
    		•  

    CHAOS study, 1996

    download pdf: vitamin E | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment vitamin E 400-800UI/d (alpha tocopherol)
    Control treatment identical placebo

    Patients

    Patients patients with angiographically proven coronary atherosclerosis
    Inclusion criteria angiographically proven coronary atherosclerosis;
    Exclusion criteria prior use of vitamin supplements containing vitamin E
    Baseline characteristics
    Women (%) 15.6% 
    age (yr) 61.8y 
    Body mass index 26.5 

    Method and design

    Randomized effectives 1035 / 967 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Follow-up duration 1.5y
    Number of centre singlecenter
    Geographic area UK
    Hypothesis Superiority
    Primary endpoint CV death, MI and non fatal MI alone
    Remarks 2 primary endpoints but no procedure to control multiplicity


    Results

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

    Cardiovascular death

    27 / 1035
         23 / 967
         1,10 [0,63;1,90]

    cardiovascular events

    41 / 1035
         64 / 967
         0,60 [0,41;0,88]

    All cause death

    36 / 1035
         26 / 967
         classic 1,29 [0,79;2,13]

    Non fatal MI

    14 / 1035
         41 / 967
         0,32 [0,18;0,58]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Cardiovascular death 27 / 1035 (2,6%) 23 / 967 (2,4%) 1,10 [0,63;1,90]  
    Non fatal MI 14 / 1035 (1,4%) 41 / 967 (4,2%) 0,32 [0,18;0,58]  
    cardiovascular events 41 / 1035 (4,0%) 64 / 967 (6,6%) 0,60 [0,41;0,88]  
    All cause death 36 / 1035 (3,5%) 26 / 967 (2,7%) 1,29 [0,79;2,13]   2934
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 2934: Stephens NG, Parsons A, Schofield PM, Kelly F, Cheeseman K, Mitchinson MJRandomised controlled trial of vitamin E in patients with coronary disease: Cambridge Heart Antioxidant Study (CHAOS)Lancet 1996 Mar 23;347:781-6
  • 0:

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Cardiovascular death 2,61% 2,38% 2,3‰
    Non fatal MI 1,35% 4,24% -28,9‰
    cardiovascular events 3,96% 6,62% -26,6‰
    All cause death 3,48% 2,69% 7,9‰

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for all type of patients

    antioxydants in cardiovascular prevention for secondary prevention



    Reference(s)

    Trials register # NA
    • Stephens NG, Parsons A, Schofield PM, Kelly F, Cheeseman K, Mitchinson MJ. Randomised controlled trial of vitamin E in patients with coronary disease: Cambridge Heart Antioxidant Study (CHAOS). Lancet 1996 Mar 23;347:781-6
      Pubmed | Hubmed | Fulltext

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