Original Paper

Vitamin Intervention for Stroke Prevention (VISP) Trial: Rationale and Design
J. David Spence^a, Virginia J. Howard^b, Lloyd E. Chambless^c, M. Rene Malinow^d, L. Creed Pettigrew^e, Meir Stampfer^f, James F. Toole<sup>g

a</sup>Robarts Research Institute, London, Ont., Canada;
^bUniversity of Alabama, Birmingham, Ala.;
^cUniversity of North Carolina, Chapel Hill, N.C.;
^dOregon Regional Primate Research Center, Beaverton, Oreg. and Oregon Health Sciences University, Portland, Oreg.;
^eUniversity of Kentucky, Lexington, Ky.;
^fHarvard School of Public Health, Boston, Mass., and
^gWake Forest University School of Medicine, Winston-Salem, N.C., USA

Address of Corresponding Author

Neuroepidemiology 2001;20:16-25 (DOI: 10.1159/000054753)

  Key Words

• Homocyst(e)ine
• Stroke
• Cerebral infarction prevention
• Cerebrovascular disorders
• Clinical trials
• Vitamin therapy
• Folic acid

  Abstract

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 B₆) and cobalamin (vitamin B₁₂) 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 B₆, 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 © 2001 S. Karger AG, Basel

  Author Contacts

James F. Toole, MD, VISP Operations Center
Stroke Research Center, Wake Forest University School of Medicine
Medical Center Boulevard
Winston-Salem, NC 27157-1078 (USA)
Tel. +1 336 716 1172, Fax +1 336 716 5477, E-Mail jtoole@wfubmc.edu

  Article Information

Number of Print Pages : 10
Number of Figures : 2, Number of Tables : 3, Number of References : 32