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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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