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
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BACKGROUND: Epidemiological studies suggest that raised plasma concentrations of total homocysteine (tHcy) may be a common, causal and treatable risk factor for atherothromboembolic ischaemic stroke. Although tHcy can be lowered effectively with small doses of folic acid, vitamin B(12) and vitamin B(6), it is not known whether lowering tHcy, by means of multivitamin therapy, can prevent stroke and other major atherothromboembolic vascular events. PURPOSE: To determine whether vitamin supplements (folic acid 2 mg, B(6) 25 mg, B(12) 500 mug) reduce the risk of stroke, and other serious vascular events, in patients with recent stroke or transient ischaemic attacks of the brain or eye (TIA). METHODS: An international, multi-centre, randomised, double-blind, placebo-controlled clinical trial. RESULTS: As of November 2001, more than 1,400 patients have been randomised from 10 countries in four continents. CONCLUSION: VITATOPS aims to recruit and follow up 8,000 patients between 2000 and 2004, and provide a reliable estimate of the safety and effectiveness of dietary supplementation with folic acid, vitamin B(12), and vitamin B(6) in reducing recurrent serious vascular events among a wide range of patients with TIA and stroke.
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