Related trials
CSPPT, 2015 - folic acid vs placebo
VITATOPS, 2010 - folic acid, vit B12 and vit B6 vs placebo
WAFACS, 2008 - folic acid, vit B12 and vit B6 vs placebo
WENBIT (vit B6), 2008 - vit B6 vs placebo
WENBIT (folic ac,B12), 2008 - folic acid, B12 vs placebo
SEARCH, 2007 - folic acid, B12 vs placebo
NORVIT (vit B6) (Bonaa), 2006 - vit B6 vs control
HOPE-2 (Lonn), 2006 - folic acid, vit B12 and vit B6 vs placebo
NORVIT (folic acid + B12) (Bonaa), 2006 - folic acid, B12 vs control
NORVIT (folic acid, B12 and vit B6) (Bonaa), 2006 - folic acid, vit B12 and vit B6 vs control
FOLARDA (Liem), 2004 - folic acid vs control
VISP (Toole), 2004 - high dose - folic acid, vit B12 and vit B6 vs low dose - folic acid, vit B12 and vit B6
GOES (Liem), 2003 - folic acid vs control
CHAOS-2, 2002 - folic acid vs placebo
SU.FOL.OM3, - folic acid, vit B12 and vit B6 vs placebo
See also:
All cardiovascular prevention clinical trials
All clinical trials of plasma homocysteine lowering intervention
All clinical trials of folic acid, vit B12 and vit B6
|
|
Treatments
Studied treatment |
folic acid 2.5mg, vitamin B6 50mg, and vitamin B12 1mg daily
|
Control treatment |
placebo
|
Patients
Patients |
women aged 42 years or older, with either a history of CVD or 3 or more coronary risk factors |
Inclusion criteria |
40 years or older, postmenopausal
or had no intention of becoming
pregnant, and had a reported
history of CVD or had at least 3 cardiac
risk factors; |
Exclusion criteria |
history of cancer (excluding nonmelanoma skin cancer) within the past 10 years, any serious non-CVD illness, or were currently using warfarin or other anticoagulants |
Baseline characteristics |
Age (yr) |
62.8 y |
Male sex |
0% |
BMI |
NA |
diabetes (%) |
21% |
|
Method and design
Randomized effectives |
2721 / 2721 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double blind |
Follow-up duration |
7.3 y |
Geographic area |
US |
Hypothesis |
Superiority |
Primary endpoint |
cardiovascular events |
Results
Endpoints and data reported in the trial's publication(s)
Endpoint |
Events (%) |
Relative Risk |
95% CI |
|
Studied treat. |
Control treat. |
Combined major cardiovascular disease |
406 / 2721 (14,9%) |
390 / 2721 (14,3%) |
1,04 |
[0,92;1,18] |
|
Myocardial infarction |
65 / 2721 (2,4%) |
74 / 2721 (2,7%) |
0,88 |
[0,63;1,22] |
|
Stroke |
79 / 2721 (2,9%) |
69 / 2721 (2,5%) |
1,14 |
[0,83;1,57] |
|
Ischemic stroke |
69 / 2721 (2,5%) |
62 / 2721 (2,3%) |
1,11 |
[0,79;1,56] |
|
Hemorrhagic stroke |
10 / 2721 (0,4%) |
6 / 2721 (0,2%) |
1,67 |
[0,61;4,58] |
|
Coronary revascularization |
253 / 2721 (9,3%) |
255 / 2721 (9,4%) |
0,99 |
[0,84;1,17] |
|
CABG |
87 / 2721 (3,2%) |
98 / 2721 (3,6%) |
0,89 |
[0,67;1,18] |
|
PCI |
192 / 2721 (7,1%) |
177 / 2721 (6,5%) |
1,08 |
[0,89;1,32] |
|
Cardiovascular death |
96 / 2721 (3,5%) |
94 / 2721 (3,5%) |
1,02 |
[0,77;1,35] |
|
Myocardial infarction, stroke, cardiovascular death |
205 / 2721 (7,5%) |
211 / 2721 (7,8%) |
0,97 |
[0,81;1,17] |
|
Total coronary heart disease |
283 / 2721 (10,4%) |
280 / 2721 (10,3%) |
1,01 |
[0,86;1,18] |
|
Total mortality |
250 / 2721 (9,2%) |
256 / 2721 (9,4%) |
0,98 |
[0,83;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]
Non fatal MI
65 / 2721
74 / 2721
0,88 [0,63;1,22]
Cardiovascular death
96 / 2721
94 / 2721
1,02 [0,77;1,35]
cardiac death
283 / 2721
280 / 2721
1,01 [0,86;1,18]
All cause death
250 / 2721
256 / 2721
0,98 [0,83;1,15]
cardiovascular events
406 / 2721
390 / 2721
1,04 [0,92;1,18]
stroke (fatal and non fatal)
79 / 2721
69 / 2721
1,14 [0,83;1,57]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
Non fatal MI
|
65 / 2721 (2,4%) |
74 / 2721 (2,7%) |
0,88 |
[0,63;1,22] |
Myocardial infarction |
0 |
Cardiovascular death
|
96 / 2721 (3,5%) |
94 / 2721 (3,5%) |
1,02 |
[0,77;1,35] |
Cardiovascular death |
0 |
All cause death
|
250 / 2721 (9,2%) |
256 / 2721 (9,4%) |
0,98 |
[0,83;1,15] |
Total mortality |
0 |
cardiovascular events
|
406 / 2721 (14,9%) |
390 / 2721 (14,3%) |
1,04 |
[0,92;1,18] |
Combined major cardiovascular disease |
0 |
stroke (fatal and non fatal)
|
79 / 2721 (2,9%) |
69 / 2721 (2,5%) |
1,14 |
[0,83;1,57] |
Stroke |
0 |
cardiac death
|
283 / 2721 (10,4%) |
280 / 2721 (10,3%) |
1,01 |
[0,86;1,18] |
Total coronary heart disease |
0 |
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 7.3 y)
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
Non fatal MI |
2,39% |
2,72% |
-0,33%
|
Cardiovascular death |
3,53% |
3,45% |
0,07%
|
All cause death |
9,19% |
9,41% |
-0,22%
|
cardiovascular events |
14,92% |
14,33% |
0,59%
|
stroke (fatal and non fatal) |
2,90% |
2,54% |
0,37%
|
cardiac death |
10,40% |
10,29% |
0,11%
|
Meta-analysis of all similar trials:
plasma homocysteine lowering intervention in cardiovascular prevention for all type of patients
Reference(s)
TrialResults-center ID |
TRC8813
|
Trials register # |
NCT00000541
|
-
Albert CM, Cook NR, Gaziano JM, Zaharris E, MacFadyen J, Danielson E, Buring JE, Manson JE.
Effect of folic acid and B vitamins on risk of cardiovascular events and total mortality among women at high risk for cardiovascular disease: a randomized trial..
JAMA 2008 May 7;299:2027-36
Pubmed
|
Hubmed
| Fulltext
-
Song Y, Cook NR, Albert CM, Van Denburgh M, Manson JE.
Effect of homocysteine-lowering treatment with folic Acid and B vitamins on risk of type 2 diabetes in women: a randomized, controlled trial..
Diabetes 2009;58:1921-8
Pubmed
|
Hubmed
| Fulltext
|