See also:

VITATOPS study, 2010	TRC10825
[NCT00097669ÐX&]	download pdf: folic acid, vit B12 and vit B6 | plasma homocysteine lowering intervention for cardiovascular prevention

Treatments

Studied treatment	folic acid and vitamins B12 and B6 in a single tablet 2-mg folic acid, 25-mg vitamin B6, and 0.5-mg vitamin B12
Control treatment	placebo

Patients

Patients	patients with recent stroke or TIA (within the past seven months)
Inclusion criteria	stroke (ischaemic or haemorrhagic) or transient ischaemic attack (eye or brain), as defi ned by standard criteria within the past 7 months;
Exclusion criteria	taking folic acid, vitamin B6, vitamin B12, or a folate antagonist (eg, methotrexate); pregnant or women of childbearing potential; limited life expectancy

Method and design

Randomized effectives	4089 / 4075 (studied vs. control)
Design	Parallel groups
Blinding	double-blind
Follow-up duration	3.4 y
Lost to follow-up	9%
Number of centre	123
Geographic area	20 countries
Hypothesis	Superiority
Primary endpoint	nonfatal stroke, nonfatal MI, vascular death

Results

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

Endpoint	Events (%)		Relative Risk	95% CI
	Studied treat.	Control treat.
Stroke, myocardial infarction, or vascular death	616 / 4089 (15,1%)	678 / 4075 (16,6%)	0,91	[0,82;1,00]
Stroke	360 / 4089 (8,8%)	388 / 4075 (9,5%)	0,92	[0,81;1,06]
Myocardial infarction	118 / 4089 (2,9%)	114 / 4075 (2,8%)	1,03	[0,80;1,33]
Vascular death	328 / 4089 (8,0%)	380 / 4075 (9,3%)	0,86	[0,75;0,99]
Non-vascular death	267 / 4089 (6,5%)	231 / 4075 (5,7%)	1,15	[0,97;1,37]
Death from any cause	614 / 4089 (15,0%)	633 / 4075 (15,5%)	0,97	[0,87;1,07]
Stroke, myocardial infarction, or any death	851 / 4089 (20,8%)	887 / 4075 (21,8%)	0,96	[0,88;1,04]
Revascularisation procedure	122 / 4089 (3,0%)	113 / 4075 (2,8%)	1,08	[0,84;1,38]
Stroke, myocardial infarction, vascular death, or revascularisation	684 / 4089 (16,7%)	740 / 4075 (18,2%)	0,92	[0,84;1,01]

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]

cardiovascular events

616 / 4089
678 / 4075
0,91 [0,82;1,00] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
cardiovascular events	616 / 4089 (15,1%)	678 / 4075 (16,6%)	0,91	[0,82;1,00]	Nonfatal stroke, nonfatal MI, vascular death	0
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 0: 13265: B vitamins in patients with recent transient ischaemic attack or stroke in the VITAmins TO Prevent Stroke (VITATOPS) trial: a randomised, double-blind, parallel, placebo-controlled trial.Lancet Neurol 2010 Aug 3;:

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 3.4 y)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
cardiovascular events	15,06%	16,64%	-1,57%

Meta-analysis of all similar trials:

plasma homocysteine lowering intervention in cardiovascular prevention for all type of patients

prevention in post stroke for patients with prior stroke or TIA

Reference(s)

TrialResults-center ID	TRC10825
Trials register #	NCT00097669ÐX&

• . Hankey GJ. The Vitamins to Prevent Stroke (VITATOPS) trial: Results of a double-blind, placebo-controlled, randomised trial of B-vitamin therapy in 8164 patients with recent transient ischaemic attack or stroke. 2010 European Stroke Conference: May 26, 2010; Barcelona, Spain.
  Pubmed | Hubmed | Fulltext
• . B vitamins in patients with recent transient ischaemic attack or stroke in the VITAmins TO Prevent Stroke (VITATOPS) trial: a randomised, double-blind, parallel, placebo-controlled trial.. Lancet Neurol 2010 Aug 3;: - 10.1016/S1474-4422(10)70187-3
  Pubmed | Hubmed | Fulltext

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