Trial name or title	A Study of VITAmins TO Prevent Stroke
Methods
Participants	Patients with stroke or TIA in the previous 7 months. Inclusion Criteria: Patients presenting within seven months of stroke (Ischaemic or hemorrhagic) or TIA. Agree to take study medication Be geographically accessible for follow-up. Provide written informed consent. Exclusion Criteria: 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.
Interventions	Folic acid: 2mg Vitamin B6: 25mg Vitamin B12: 500 micrograms
Outcomes	Primary: Non-fatal stroke Non-fatal myocardial infarction Death due to vascular causes. Secondary: TIA Revascularization procedures Dementia Depression.
Starting date	November 1998
Contact information	Julia Pizzi +61 8 9224 7004 VITATOPS@health.wa.gov.au Michelle Tang +61 8 9224 3336 VITATOPS@health.wa.gov.au
Notes	Region: Australia: Study Design: prevention, randomised, double-blind, placebo control, parallel assignment, safety/efficacy study Sample size calculation: To reliably identify a 15% reduction in relative risk of the primary outcome event from 8% to 6.8% per year with an alpha of 0.05 and power of 80%, 8,000 patients need to be randomised and followed-up for an average of two years Current progress: As of November, 2004, more than 4,400 patients have been randomised in 73 centres in 19 countries in five continents: Australia, Austria, Belgium, Brazil, Hong Kong, Italy, Malaysia, Moldova, Netherlands, New Zealand, Pakistan, Philippines, Portugal, Republic of Georgia, Serbia & Monte Negro, Singapore, Sri Lanka, United Kingdom, and United States

^*Authors asked to the author for getting complete data; however, they did not send the information.

NA: not available.