VITATOPS: A Study of VITAmins TO Prevent Stroke

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.

Conditions

• Stroke
• Transient Ischemic Attack

Interventions

DRUG

Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo

multivitamin

OTHER

Placebo

Sponsors & Collaborators

• National Health and Medical Research Council, Australia

  collaborator OTHER

• National Heart Foundation, Australia

  collaborator OTHER

• Medical Health Research Infrastructure Council, Australia

  collaborator OTHER

• VITATOPS

  lead OTHER_GOV

Principal Investigators

• Graeme Hankey, MBBS/MD · Royal Perth Hospital / University of Western Australia

• Ross Baker, MBBS/BMedSc · Royal Perth Hospital

• John Eikelboom, MBBS/FRACP · Royal Perth Hospital

• Konrad Jamrozik, MBBS · The University of Queensland

• Frank van Bockxmeer, BSc/PhD · Royal Perth Hospital

• Siobhan Hickling, BSc/MPH · The University of Western Australia

• Anna Gelavis, BPharm · Royal Perth Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1998-11-30

Primary Completion

2009-06-30

Completion

2009-06-30

Countries

• United States
• Australia
• Austria
• Belgium
• Brazil
• Georgia
• Hong Kong
• India
• Italy
• Malaysia
• Moldova
• Netherlands
• New Zealand
• Pakistan
• Philippines
• Portugal
• Serbia
• Singapore
• Sri Lanka
• United Kingdom

Study Locations