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

J. David Spence, Virginia J. Howard, Lloyd E. Chambless, M. Rene Malinow, L. Creed Pettigrew, Meir Stampfer, James F. Toole

Research output: Contribution to journalArticlepeer-review

98 Scopus citations

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.

Original languageEnglish
Pages (from-to)16-25
Number of pages10
JournalNeuroepidemiology
Volume20
Issue number1
DOIs
StatePublished - 2001

Keywords

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

ASJC Scopus subject areas

  • Epidemiology
  • Clinical Neurology

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