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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<i>Background:</i> 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<sub>12</sub> and vitamin B<sub>6</sub>, it is not known whether lowering tHcy, by means of multivitamin therapy, can prevent stroke and other major atherothromboembolic vascular events. <i>Purpose:</i> To determine whether vitamin supplements (folic acid 2 mg, B<sub>6</sub> 25 mg, B<sub>12</sub> 500 µg) 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). <i>Methods:</i> An international, multi-centre, randomised, double-blind, placebo-controlled clinical trial. <i>Results:</i> As of November 2001, more than 1,400 patients have been randomised from 10 countries in four continents. <i>Conclusion:</i> 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<sub>12</sub>, and vitamin B<sub>6</sub> in reducing recurrent serious vascular events among a wide range of patients with TIA and stroke.
