VITAMIN INTERVENTION FOR STROKE PREVENTION (VISP) CLINICAL TRIAL

VISP试验是一项双盲、随机临床试验 旨在确定除了最佳医疗/手术外， 高剂量叶酸，B6和B12补充剂将减少 与低剂量的这些维生素相比， 这项研究， 由NIH支持，是第一个干预临床试验， 在世界上进行。 1997年8月至1998年12月， 患者进行了筛选采血，并符合以下条件 从美国54家诊所测定的同型半胱氨酸[H（e）]水平， 加拿大 筛查将持续到2000年。 博士 Malinow的实验室是中心实验室， 同型半胱氨酸和B族维生素。 最初的计算 表明3600名非致残性中风患者（分配到两个 武器）将提供统计能力，以检测潜在的有益的 影响互动。 到目前为止，已有1400多名患者 随机化并进行随访，以确定是否 维生素治疗会降低中风、心肌梗塞的发生率， 梗塞和死亡。 后续行动估计将于2010年12月15日至2011年12月31日完成。 2002年底。 与维克森林大学学院的分包合同 医学出版物无

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