VITATOPS: A Study of VITAmins TO Prevent Stroke

Completed · Not applicable · Has a placebo group

Conditions studied: Stroke, Transient Ischemic Attack

In brief

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.

Key facts

Study ID

NCT00097669

Run by

VITATOPS

People needed

8164

Starts

1998-11-01

Expected to finish

2009-06-01

Last updated by the study team

2020-09-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Taking folic acid or B6 on medical advice
• Use of vitamin supplements containing folate, B6 or B12 (unless patient agrees to take study medication instead of the vitamin supplements which they usually take)
• Taking Methotrexate for any reason
• Pregnancy or women of child-bearing potential who are at risk of pregnancy
• Limited life expectancy

Where it is running

• Abington Memorial Hospital — Abington, Pennsylvania, United States
• South Carolina VA Hospital — Columbia, South Carolina, United States
• University of South Carolina — Columbia, South Carolina, United States
• Central Coast Neuroscience Research — Gosford, Australia
• Bankstown Hospital — New South Wales, Australia
• John Hunter Hospital — New South Wales, Australia
• Liverpool Hospital — New South Wales, Australia
• Royal Perth Hospital — Perth, Australia
• Greenslopes Hospital — Queensland, Australia
• Nambour Hospital — Queensland, Australia
• Flinders & Griffiths — South Australia, Australia
• Royal Hobart Hospital — Tasmania, Australia
• Alfred Hospital — Victoria, Australia
• Beleura & Frankston Hospital — Victoria, Australia
• Box Hill Hospital — Victoria, Australia
• National Stroke Research Institute - Austin Health — Victoria, Australia
• Fremantle Hospital — Western Australia, Australia
• Joondalup Hospital — Western Australia, Australia
• Sir Charles Gairdner Hospital — Western Australia, Australia
• Karl-Franzens University Graz — Graz, Austria
• Algemeen Ziekenhuis Sint-Jan Autonome Verzorgingsinstelling — Bruges, Belgium
• Universidade Federal Fluminense & Universidade Federal do Rio de Janeiro — Rio de Janeiro, Brazil
• Sarajishvili Institute of Neurology and Neurosurgery — Tbilisi, Georgia
• Queen Mary Hospital — Pokfulam, Hong Kong
• JFK Hospital / Seton Hall University — New York, New York, United States

Full record on ClinicalTrials.gov

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