VITATOPS trial

There is an association between the rare inborn recessive condition of homocystinemia and arterial and venous thrombosis, and observational data link coronary heart disease, stroke, and venous thromboembolism with increasing plasma homocysteine (Wald et al. 2002, 2004). This led to trials of foUc acid and pyridoxine supplementation to lower homocysteine levels (Hankey 2002 Hankey and Eikelboom 2005). Results from such trials have so far been disappointing the Vitamin Intervention for Stroke Prevention Study (VISP) and the Norwegian Vitamin Trial (NORVIT) (Toole et al. 2004 Bonaa et al. 2006) trials showed no treatment effect on recurrent stroke, coronary events or deaths. Preliminary results from the Study of Vitamins to Prevent Stroke (VITATOPS) trial have shown no evidence of reduced levels of iirflammation, endothelial dysfunction, or the hypercoagulability postulated to be increased by elevated homocysteine levels in patients with previous TIA or stroke treated with foUc acid, vitamin B12 and vitamin Bs... 

Homocysteine-lowering treatment with folic acid, cobalamin and pyridoxine does not reduce blood markers of inflammation, endothelial dysfunction or hypercoagulability in patients with previous transient ischemic attack or stroke a randomized substudy of the VITATOPS trial. Stroke 36 144-146... 

Anonymous, 2010. 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 Neurology. 9 855-865. 

Different epidemiological studies suggest that raised plasma concentrations of total Hey may be a common, causal and treatable risk factor for athero-thromboembolic ischemic stroke. Therefore, a study aimed to assess the effect of Vitamins to Prevent Stroke (VITATOPS)—an international, multi-centre, randomized, double-blind, placebo-controlled clinical trial using a multivitamin therapy (folic acid 2 mg, vitamin Bg 25 mg, vitamin B12 500 pg) has been carried out. A total of 8000 patients were randomized and followed up for a mean period of 2.5 years (range 1-8 years) (VITATOPS Trial Study Group 2002). 

Some findings of this clinical trial are that daily administration of folic acid, vitamin Bg and vitamin B12 to patients with recent stroke or transient ischemic attack was safe but did not seem to be more effective than placebo in reducing the incidence of major vascular events. These results do not support the use of B vitamins to prevent recurrent stroke. The results of ongoing trials and an individual patient data meta-analysis will add statistical power and precision to present estimates of the effect of B vitamins (VITATOPS Trial Study Group 2010). 

VITATOPS Trial Study Group, 2002. The VITATOPS (Vitamins to Prevent Stroke) Trial rationale and design of an international, large, simple, randomised trial of homocysteine-lowering multivitamin therapy in patients with recent transient ischaemic attack or stroke. Cerebrovascular Diseases. 13. 120-126. 

Almeida, O.P., Marsh, K., Alfonso, H., Flicker, L., Davis, T.M., and Hankey, G.J, 2010. B-vitamins reduce the long-term risk of depression after stroke The VITATOPS-DEP trial. Annals of Neurology. 68 503-510. 

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