Not Signed In -
Stroke |
Brain Attack; Carotid Endarterectomy; Cerebrovascular Disease |
Clinical Trial: VITATOPS: A Study of VITAmins TO Prevent Stroke
This study is currently recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention |
|---|---|
| Stroke Transient Ischemic Attack | Drug: folic acid 2mg Drug: Vitamin B6 25mg Drug: Vitamin B12 500ug |
MedlinePlus related topics: Stroke; Transient Ischemic Attack
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: VITATOPS - A study of VITAmins TO Prevent Stroke
Secondary Outcomes: TIA; Revascularization procedures; Dementia; Depression
Expected Total Enrollment: 8000
Study start: November 1998; Expected completion: December 2007
Last follow-up: December 2006; Data entry closure: December 2006
Background: Epidemiological studies suggest that raised plasma concentrations of total homocysteine (tHcy) may be a common, causal and treatable risk factor for atherothromboembolic ischemic stroke, dementia and depression. Although tHcy can be lowered effectively with small doses of folic acid, vitamin B12 and vitamin B6, it is not known whether lowering tHcy, by means of multivitamin therapy, can prevent stroke and other major atherothromboembolic vascular events, dementia and depression.
Purpose: To determine whether vitamin supplements (folic acid 2 mg, B6 25 mg, B12 500 ug) reduce the risk of stroke, other serious vascular events, dementia and depression in patients with recent stroke or transient ischemic attacks of the brain or eye (TIA).
Methods: An international, multi-center, randomized, double-blind, placebo-controlled clinical trial.
Subjects: Patients with stroke or TIA in the previous 7 months.
Primary outcome measure: Non-fatal stroke, non-fatal myocardial infarction, or death due to vascular causes.
Secondary outcome measures: TIA, Revascularisation procedures, Dementia, Depression.
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 randomized and followed-up for an average of two years.
Current progress: As of November, 2004, more than 4,400 patients have been randomized in 73 centers 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.
Conclusion: VITATOPS aims to recruit and follow up 8,000 patients between 2000 and 2006, and provide a reliable estimate of the safety and effectiveness of dietary supplementation with folic acid, vitamin B12, and vitamin B6 in reducing recurrent serious vascular events, dementia and depression among a wide range of patients with stroke and TIA.
Eligibility
Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- 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
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
Location and Contact Information
Michelle Tang +61 8 9224 3336 VITATOPS@health.wa.gov.au
New Jersey
JFK Hospital / Seton Hall University, New York, New Jersey, 08818, United States; Recruiting
Michael Moussouttas, MD, Sub-Investigator
Ohio
Ohio State University, Columbus, Ohio, United States; Recruiting
Andrew Slivka, MD, Sub-Investigator
Pennsylvania
Abington Memorial Hospital, Abington, Pennsylvania, 19001, United States; Recruiting
Kevin Booth, MD, Sub-Investigator
South Carolina
University of South Carolina, Columbia, South Carolina, 29203, United States; Recruiting
Te-Long Hwang, MD, Sub-Investigator
South Carolina VA Hospital, Columbia, South Carolina, 29203, United States; Recruiting
Te-Long Hwang, MD, Sub-Investigator
Australia, Western Australia
Royal Perth Hospital, Perth, Western Australia, 6000, Australia; Recruiting
Graeme Hankey, MBBS/MD, Principal Investigator
Austria
Karl-Franzens University Graz, Graz, A-8036, Austria; Recruiting
Reinhold Schmidt, MD, Sub-Investigator
Belgium
Algemeen Ziekenhuis Sint-Jan Autonome Verzorgingsinstelling, Brugge, 8000, Belgium; Recruiting
Geert Vanhooren, MD, Sub-Investigator
Brazil
Universidade Federal Fluminense & Universidade Federal do Rio de Janeiro, Rio de Janeiro, 24220-100, Brazil; Recruiting
Gabriel de Freitas, MD, Sub-Investigator
Georgia
Sarajishvili Institute of Neurology and Neurosurgery, Tbilisi, 380092, Georgia; Recruiting
Alexander Tsiskaridze, MD, Sub-Investigator
Italy
University of Perugia, Perugia, 06126, Italy; Recruiting
Paolo Gresele, MD, Sub-Investigator
Ospedale di Macerata, Macerata, 60100, Italy; Recruiting
Giorgio Giuliani, MD 390733257205 ggiuliani@asl9.marche.it
Luigino De Dominicis, MD, Sub-Investigator
Giorgio Giuliani, MD, Sub-Investigator
Gabriele Marchegiani, MD, Sub-Investigator
Perugia Stroke Service & Citta Della Peive, Perugia, 06087, Italy; Recruiting
Stefano Ricci, MD, Sub-Investigator
IRCCS Fondazione Istituto Neurologico C Mondino, Pavia, 27100, Italy; Recruiting
Giuseppe Micieli, MD, Sub-Investigator
Ospedale di Circolo de Busto Arsizio, Busto Arsizio, 21052, Italy; Recruiting
Roberto Cattaneo, MD, Sub-Investigator
Moldova, Republic of
City Emergency Hospital, Chishinau, 2004, Moldova, Republic of; Recruiting
Stanislav Groppa, MD, Sub-Investigator
Netherlands
Oosterscheldeziekenhuis, Goes, 4460, Netherlands; Recruiting
Sips, MD, Sub-Investigator
University Medical Center Utrecht, Utrecht, 3584, Netherlands; Recruiting
Jan van Gijn, MD, Sub-Investigator
Slotervaartziekenhuis, Amsterdam, 1066, Netherlands; Recruiting
Jaap Van der Sande, MD, Sub-Investigator
Portugal
Hospital Distrital de Oliverira de Azemeis, Oliveria de Azemeis, 3720-275, Portugal; Recruiting
Miguel Veloso, MD, Sub-Investigator
Hospital Visconde de Salreu, Estarreja, 3864-756, Portugal; Recruiting
Ana Paula Martins, MD, Sub-Investigator
Hospital de Santa Maria, Lisboa, 1649-035, Portugal; Recruiting
Jose M Ferro, MD, Sub-Investigator
Hospital Geral de Santo Antonio, Porto, 4099-001, Portugal; Recruiting
Manuel Correia, MD, Sub-Investigator
United Kingdom
North Tyneside District General Hospital, North Shields, NE29 8NH, United Kingdom; Recruiting
Richard Curless, MD, Sub-Investigator
The Royal Victoria Hospital, Belfast, BT12 6BA, United Kingdom; Recruiting
Michael Watt, MD, Sub-Investigator
Western Infirmary, Glasgow, Glasgow, G11 6NT, United Kingdom; Recruiting
Kennedy Lees, MD, Sub-Investigator
Western General Hospital, Edinburgh, Edinburgh, EH4 2XU, United Kingdom; Recruiting
Julie Tickner 131-537-3387 Julie.Tickner@luht.scot.nhs.uk
Martin Dennis, MD, Sub-Investigator
Royal Victoria Infirmary, Newcastle, Newcastle, NE2 4 AA, United Kingdom; Recruiting
Helen Rodgers, MD, Sub-Investigator
Redbridge Health Care, Barking, IG11 9LX, United Kingdom; Recruiting
Kantha Niranjan, MD, Sub-Investigator
Bronglais General Hospital, Ceredigion, SY23 1ER, United Kingdom; Recruiting
Philip Jones, MD, Sub-Investigator
Barnsley District Hospital, Barnsley, S75 2EP, United Kingdom; Recruiting
MK Bazzaz, MD, Sub-Investigator
William Harvey Hospital, Kent, TN240LZ, United Kingdom; Recruiting
David Smithard, MD, Sub-Investigator
St Mary's Paddington Hospital, Paddington, W2 1NY, United Kingdom; Recruiting
Jeremy Chataway, MD, Sub-Investigator
Kingston Hospital, Surrey, KT2 7QB, United Kingdom; Recruiting
Ali Al-Memar, MD, Sub-Investigator
Nottingham City Hospital, Nottingham, NG5 1PB, United Kingdom; Recruiting
Philip Bath, MD, Sub-Investigator
Mark Willmot, MD, Sub-Investigator
St Luke's Hospital, Huddersfield, HD4 5RQ, United Kingdom; Recruiting
Badr El din Ahmed Dafalla, MD, Sub-Investigator
Yugoslavia
University of Novi Sad - Neurology & Neurosurgery, Novi Sad, 21000, Yugoslavia; Recruiting
Ivana Divjak, MD, Sub-Investigator
Graeme Hankey, MBBS/MD, Principal Investigator, Royal Perth Hospital / University of Western Australia
Ross Baker, MBBS/BMedSc, Study Director, Royal Perth Hospital
John Eikelboom, MBBS/FRACP, Study Director, Royal Perth Hospital
Konrad Jamrozik, MBBS, Study Director, University of Queensland
Frank van Bockxmeer, BSc/PhD, Study Director, Royal Perth Hospital
Siobhan Hickling, BSc/MPH, Study Director, University of Western Australia
Anna Gelavis, BPharm, Study Director, Royal Perth Hospital
More Information
National Heart Foundation
National Institute of Neurological Disorders and Stroke
National Stroke Foundation
Stroke Society of Australasia Inc.
Record last reviewed: November 2004
Last Updated: March 14, 2005
Record first received: November 24, 2004
ClinicalTrials.gov Identifier: NCT00097669
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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