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 (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
NORVIT (vit B6) (Bonaa), 2006 - vit B6 vs control
HOPE-2 (Lonn), 2006 - folic acid, vit B12 and vit B6 vs placebo
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, B12
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Treatments
Studied treatment |
folic acid 0.8mg, vit B12 0.4mg daily
|
Control treatment |
placebo
|
Remarks |
4 arms: folic acid+B12+B6, folic ac+B12, B6, placebo (2x2 factorial design B6 vs PBO, folic ac+B12 vs pbo)
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Patients
Patients |
adult participants undergoing coronary angiography
|
Exclusion criteria |
alcohol abuse; serious mental illness; cancer
|
Baseline characteristics |
Age (yr) |
61.5 yr |
Male sex |
78% |
BMI |
26.9 |
diabetes (%) |
NA |
|
Method and design
Randomized effectives |
772 / 780 (studied vs. control) |
Design |
Factorial plan |
Blinding |
double blind |
Follow-up duration |
38.4 mo |
Number of centre |
2 |
Geographic area |
Norway |
Hypothesis |
Superiority |
Primary endpoint |
all death, MI, unstable angina, stroke |
Remarks |
|
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
All cause death
38 / 772
30 / 780
classic
1,28 [0,80;2,04]
stroke (fatal and non fatal)
17 / 772
19 / 780
0,90 [0,47;1,73]
Cancer
39 / 772
31 / 780
classic
1,27 [0,80;2,02]
Non fatal MI
76 / 772
58 / 780
1,32 [0,95;1,84]
cardiovascular events
125 / 772
97 / 780
1,30 [1,02;1,66]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
All cause death
|
38 / 772 (4,9%) |
30 / 780 (3,8%) |
1,28 |
[0,80;2,04] |
|
11312 |
Non fatal MI
|
76 / 772 (9,8%) |
58 / 780 (7,4%) |
1,32 |
[0,95;1,84] |
|
11312 |
cardiovascular events
|
125 / 772 (16,2%) |
97 / 780 (12,4%) |
1,30 |
[1,02;1,66] |
|
11312 |
stroke (fatal and non fatal)
|
17 / 772 (2,2%) |
19 / 780 (2,4%) |
0,90 |
[0,47;1,73] |
|
11312 |
Cancer
|
39 / 772 (5,1%) |
31 / 780 (4,0%) |
1,27 |
[0,80;2,02] |
|
11312 |
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
11312: Ebbing M, Bleie �, Ueland PM, Nordrehaug JE, Nilsen DW, Vollset SE, Refsum H, Pedersen EK, Nyg�rd OJAMA 2008;300:795-804
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Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction (for a follow-up of 38.4 mo)
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
All cause death |
4,92% |
3,85% |
1,1%
|
Non fatal MI |
9,84% |
7,44% |
2,4%
|
cardiovascular events |
16,19% |
12,44% |
3,8%
|
stroke (fatal and non fatal) |
2,20% |
2,44% |
-0,23%
|
Cancer |
5,05% |
3,97% |
1,1%
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Meta-analysis of all similar trials:
plasma homocysteine lowering intervention in cardiovascular prevention for all type of patients
Reference(s)
TrialResults-center ID |
TRC9991
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Trials register # |
NCT00354081
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|