VITAMIN INTERVENTION FOR STROKE PREVENTION (VISP) CLINICAL TRIAL

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The VISP trial is a double-masked, randomized clinical trial designed to determine if, in addition to best medical/surgical management, high dose folate, B6, and B12 supplements will reduce recurrent stroke compared to low doses of these vitamins. This study, supported by NIH, is the first intervention clinical trial to be conducted in the world. From August 1997 through December 1998, 2214 patients had screening blood drawn and eligibility with respect to homocyst(e)ine [H(e)] level determined from 54 clinics in the US and Canada. Screening will be continual until the year 2000. Dr. Malinow=s laboratory is the Central Laboratory where analysis of homocyst(e)ine and B-vitamins is conducted. Initial calculations indicated that 3600 non-disabling stroke patients (assigned to two arms) will provide statistical power to detect a potential beneficial effect on the interaction. To date, over 1400 patients have been randomized and are being followed in order to determine whether vitamin treatment will reduce the incidence of stroke, myocardial infarction and death. Follow-ups are estimated to be completed by the end of 2002. FUNDING Subcontract with Wake Forest University School of Medicine PUBLICATIONS None