Vitamin intervention for stroke prevention (VISP) trial: Rationale and design

被引:88
作者
Spence, JD
Howard, VJ
Chambless, LE
Malinow, MR
Pettigrew, LC
Stampfer, M
Toole, JF
机构
[1] Wake Forest Univ, Bowman Gray Sch Med, Ctr Stroke Res, VISP Operat Ctr, Winston Salem, NC 27157 USA
[2] Robarts Res Inst, London, ON N6A 5C1, Canada
[3] Univ Alabama, Birmingham, AL USA
[4] Univ N Carolina, Chapel Hill, NC USA
[5] Oregon Reg Primate Res Ctr, Beaverton, OR 97006 USA
[6] Oregon Hlth Sci Univ, Portland, OR 97201 USA
[7] Univ Kentucky, Lexington, KY USA
[8] Harvard Univ, Sch Publ Hlth, Boston, MA 02115 USA
关键词
homocyst(e)ine; stroke; cerebral infarction prevention; cerebrovascular disorders; clinical trials; vitamin therapy; folic acid;
D O I
10.1159/000054753
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
Elevated plasma levels of homocyst(e)ine [H(e)] are surprisingly common and strongly associated with endothelial dysfunction and a marked increase in vascular risk. Treatment with a combination of folic acid, pyridoxine (vitamin B-6) and cobalamin (vitamin B-12) reduces plasma H(e) levels in most cases, restores endothelial function, and regresses carotid plaque, but there is no evidence that such treatment will reduce clinical events. The Vitamin Intervention for Stroke Prevention (VISP) study is a double-masked, randomized, multicenter clinical trial designed to determine if, in addition to best medical/surgical management, high-dose folic acid, vitamin Bg, and Vitamin B12 supplements will reduce recurrent stroke compared to lower doses of these vitamins. Patients at least 35 years old with a nondisabling ischemic stroke within 120 days, and screening plasma H(e) > the 25th percentile of benchmark population data are eligible. Secondary endpoints are myocardial infarction or fatal coronary heart disease. This paper describes the design and rationale of the study. Copyright (C) 2001 S. Karger AG, Basel.
引用
收藏
页码:16 / 25
页数:10
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