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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

PHS II (multivitamin), 2012 - combination vs placebo

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 vitamin E, 2007 - vitamin E vs placebo

WACS vitamin C, 2007 - vitamin C vs placebo

WACS beta-caroten, 2007 - beta carotene 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

WAVE (Waters), 2002 - combination vs placebo

HPS antioxidant, 2002 - combination vs placebo

PPP, 2001 - vitamin E vs control

AREDS, 2001 - vitamin E vs placebo

HATS, 2001 - combination vs placebo

SPACE, 2000 - vitamin E vs placebo

ASAP, 2000 - vitamin E vs placebo

HOPE, 2000 - vitamin E vs placebo

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

WHS beta carotene, 1999 - beta carotene vs placebo

GISSI, 1999 - vitamin E vs control

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



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antioxydants
  • All clinical trials of vitamin C
  •  
     WACS vitamin C study, 2007 TRC7996 
    [NCT00000541] download pdf: vitamin C | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment vitamin C (ascorbic acid) 500 mg/d
    Control treatment placebo
    Remarks 2x2x2 factorial design testing the effects of ascorbic acid (500 mg/d), vitamin E (600 IU every other day), and beta carotene (50 mg every other day)

    Patients

    Patients female health professionals at increased risk (40 years or older with a history of CVD or 3 or more CVD risk factors)
    Inclusion criteria Women, aged 40 and over, at high risk, with a history of coronary artery disease, carotid endarterectomy, peripheral artery surgery, or three or more coronary heart disease risk factors
    Exclusion criteria self-reported history of cancer (excluding nonmelanoma skin cancer) within the past 10 years; any serious non-CVD illness; currently using warfarin sodium or other anticoagulants
    Baseline characteristics
    Women (%) 100% 
    age (yr) 60.6 y 
    Body mass index 30.3 

    Method and design

    Randomized effectives 4087 / 4084 (studied vs. control)
    Blinding double blind
    Follow-up duration 9.4 years
    Geographic area US
    Hypothesis Superiority
    Primary endpoint MI, stroke, coronary revascularization, CVD death
    Remarks

    Remarks / Comments



    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Major CVD (MI, stroke, revascularization procedure or death due to cardiovascular cause) 731 / 4087 (17,9%) 719 / 4084 (17,6%) 1,02 [0,93;1,12]
    MI, stroke,CVD death 419 / 4087 (10,3%) 415 / 4084 (10,2%) 1,01 [0,89;1,15]
    MI 140 / 4087 (3,4%) 134 / 4084 (3,3%) 1,04 [0,83;1,32]
    Fatal MI 15 / 4087 (0,4%) 19 / 4084 (0,5%) 0,79 [0,40;1,55]
    Nonfatal MI 125 / 4087 (3,1%) 115 / 4084 (2,8%) 1,09 [0,85;1,39]
    Revascularization 446 / 4087 (10,9%) 443 / 4084 (10,8%) 1,01 [0,89;1,14]
    Total CHD 510 / 4087 (12,5%) 489 / 4084 (12,0%) 1,04 [0,93;1,17]
    Stroke 138 / 4087 (3,4%) 160 / 4084 (3,9%) 0,86 [0,69;1,08]
    Ischemic stroke 123 / 4087 (3,0%) 148 / 4084 (3,6%) 0,83 [0,66;1,05]
    Hemorrhagic stroke 13 / 4087 (0,3%) 12 / 4084 (0,3%) 1,08 [0,49;2,37]
    Fatal stroke 15 / 4087 (0,4%) 18 / 4084 (0,4%) 0,83 [0,42;1,65]
    Nonfatal stroke 123 / 4087 (3,0%) 142 / 4084 (3,5%) 0,87 [0,68;1,10]
    TIA 203 / 4087 (5,0%) 218 / 4084 (5,3%) 0,93 [0,77;1,12]
    CVD death 206 / 4087 (5,0%) 189 / 4084 (4,6%) 1,09 [0,90;1,32]
    Total mortality 504 / 4087 (12,3%) 491 / 4084 (12,0%) 1,03 [0,91;1,15]

    Endpoints used by the meta-analysis and data retained for this trial

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

    Coronary event

    140 / 4087
    134 / 4084
    1,04 [0,83;1,32]

    stroke (fatal and non fatal)

    138 / 4087
    160 / 4084
    0,86 [0,69;1,08]

    ischemic stroke

    123 / 4087
    148 / 4084
    0,83 [0,66;1,05]

    Cardiovascular death

    206 / 4087
    189 / 4084
    1,09 [0,90;1,32]

    cardiovascular events

    419 / 4087
    415 / 4084
    1,01 [0,89;1,15]

    All cause death

    504 / 4087
    491 / 4084
    1,03 [0,91;1,15]

    Non fatal stroke

    123 / 4087
    142 / 4084
    0,87 [0,68;1,10]

    Haemmorhagic stroke

    13 / 4087
    12 / 4084
    classic 1,08 [0,49;2,37]

    Non fatal MI

    125 / 4087
    115 / 4084
    1,09 [0,85;1,39]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 140 / 4087 (3,4%) 134 / 4084 (3,3%) 1,04 [0,83;1,32] MI 
    stroke (fatal and non fatal) 138 / 4087 (3,4%) 160 / 4084 (3,9%) 0,86 [0,69;1,08] Stroke  0
    ischemic stroke 123 / 4087 (3,0%) 148 / 4084 (3,6%) 0,83 [0,66;1,05] Ischemic stroke  0
    Cardiovascular death 206 / 4087 (5,0%) 189 / 4084 (4,6%) 1,09 [0,90;1,32] CVD death 
    cardiovascular events 419 / 4087 (10,3%) 415 / 4084 (10,2%) 1,01 [0,89;1,15] MI, stroke,CVD death 
    All cause death 504 / 4087 (12,3%) 491 / 4084 (12,0%) 1,03 [0,91;1,15] Total mortality 
    Non fatal stroke 123 / 4087 (3,0%) 142 / 4084 (3,5%) 0,87 [0,68;1,10] Nonfatal stroke 
    Haemmorhagic stroke 13 / 4087 (0,3%) 12 / 4084 (0,3%) 1,08 [0,49;2,37] Hemorrhagic stroke  0
    Non fatal MI 125 / 4087 (3,1%) 115 / 4084 (2,8%) 1,09 [0,85;1,39] Nonfatal MI 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 9.4 years)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 3,43% 3,28% 0,14%
    stroke (fatal and non fatal) 3,38% 3,92% -0,54%
    ischemic stroke 3,01% 3,62% -0,61%
    Cardiovascular death 5,04% 4,63% 0,41%
    cardiovascular events 10,25% 10,16% 0,09%
    All cause death 12,33% 12,02% 0,31%
    Non fatal stroke 3,01% 3,48% -0,47%
    Haemmorhagic stroke 3,18‰ 2,94‰ 0,02%
    Non fatal MI 3,06% 2,82% 0,24%

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for all type of patients

    antioxydants in cardiovascular prevention for secondary prevention



    Reference(s)

    TrialResults-center ID TRC7996
    Trials register # NCT00000541
    • Cook NR, Albert CM, Gaziano JM, Zaharris E, MacFadyen J, Danielson E, Buring JE, Manson JE. A randomized factorial trial of vitamins C and E and beta carotene in the secondary prevention of cardiovascular events in women: results from the Women's Antioxidant Cardiovascular Study.. Arch Intern Med 2007;167:1610-8
      Pubmed | Hubmed | Fulltext
    • Bassuk SS, Albert CM, Cook NR, Zaharris E, MacFadyen JG, Danielson E, Van Denburgh M, Buring JE, Manson JE. The Women's Antioxidant Cardiovascular Study: design and baseline characteristics of participants.. J Womens Health (Larchmt) 2004;13:99-117 - 10.1089/154099904322836519
      Pubmed | Hubmed | Fulltext

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