At a glance
ClinicalIndex Comparison Record- ✓Patients presenting within seven months of stroke (ischemic or hemorrhagic) or TIA
- ✓Agree to take study medication
- ✓Be geographically accessible for follow-up
- ✓Provide written informed consent
- ✕Taking folic acid or B6 on medical advice
- ✕Use of vitamin supplements containing folate, B6 or B12 (unless patient agrees to discontinue and take study medication instead)
- ✕Taking Methotrexate for any reason
- ✕Pregnancy or women of child-bearing potential who are at risk of pregnancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
VITATOPS - A Study of VITAmins TO Prevent Stroke
In Brief
A clinical study evaluating Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo and Placebo for Stroke and Transient Ischemic Attack. Completed, enrolled 8,164 participants across 111 sites in 20 countries.
Detailed Summary
The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug, B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial infarction) and vascular death in patients with recent stroke or transient ischemic attack (TIA). All patients presenting to one of the participating neurologists or general physicians within seven months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible for this trial. Eligible patients will be randomized in a double-blind fashion to receive multi-vitamins or placebo, 1 tablet daily. The primary outcome event is the composite event "stroke, myocardial infarction, or death from any vascular cause", whichever occurs first. Our target is to recruit a total of 8,000 patients over the next two years with a median follow-up of 2.5 years. Recruitment to the trial began in November 1998 and is planned to continue until December 2005. We aim to complete final follow-up by the end of 2006. However, the Steering Committee will be flexible in dictating the need for ongoing recruitment and continuing follow-up, depending on the overall rate of the primary outcome event in the entire cohort at each interim analysis.
Study Details
Timeline
Interventions
multivitamin