VITATOPS: A Study of VITAmins TO Prevent Stroke
VITATOPS - A Study of VITAmins TO Prevent Stroke
1 other identifier
interventional
8,164
19 countries
110
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Nov 1998
Longer than P75 for not_applicable stroke
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 24, 2004
CompletedFirst Posted
Study publicly available on registry
November 25, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
September 25, 2020
CompletedSeptember 25, 2020
January 1, 2014
10.6 years
November 24, 2004
January 20, 2014
September 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes
The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).
Study Arms (2)
Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug)
ACTIVE COMPARATORActive Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.
Placebo Tablet
PLACEBO COMPARATORPlacebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids.
Interventions
multivitamin
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VITATOPSlead
- National Health and Medical Research Council, Australiacollaborator
- National Heart Foundation, Australiacollaborator
- Medical Health Research Infrastructure Council, Australiacollaborator
Study Sites (111)
JFK Hospital / Seton Hall University
New York, New York, United States
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
Prince of Wales Hospital
Shatin, Hong Kong
Rajah Muthaiah Medical College
Annāmalainagar, India
St John's Medical College Hospital
Bangalore, India
SP Medical College
Bikaner, India
Baby Memorial Hospital
Calicut, India
KS Hospital
Chennai, India
Care Hopstial
Hyderabad, India
Mahaveer Hospital & Research Centre
Hyderabad, India
Mediciti Hospital
Hyderabad, India
MGM Medical College & MY Hospital
Indore, India
Monilek Hospital
Jaipur, India
Amrita Institute of Medical Science
Kochi, India
Centauri, The Albert Road Clinic
Kolkata, India
CSMMU
Lucknow, India
Christian Medical College & Hospital
Ludhiana, India
G.B. Pant Hospital
New Delhi, India
Sir Ganga Ram Hospital
New Delhi, India
Sadhbavana Medical & Heart Institute
Patiaala, India
Railway Hospital
Perambūr, India
Poona Hospital
Pune, India
Ruby Hall Clinic
Pune, India
Neurocenter
Trichy, India
Care Hospital
Visakhapatnam, India
Mahatma Gandhi Institute
Wardha, India
Spedali Civili Di Brescia
Brescia, Italy
Ospedale di Circolo de Busto Arsizio
Busto Arsizio, Italy
Ospedale di Macerata
Macerata, Italy
IRCCS Fondazione Istituto Neurologico C Mondino
Pavia, Italy
Perugia Stroke Service & Citta Della Peive
Perugia, Italy
University of Perugia
Perugia, Italy
Ospedale R Guzzardi
Vittoria, Italy
Hospital Universiti Sains Malaysia
Kelantan, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Malaysia
City Emergency Hospital
Chishinau, Moldova
Slotervaartziekenhuis
Amsterdam, Netherlands
Oosterscheldeziekenhuis
Goes, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Auckland Hospital
Auckland, New Zealand
Hawkes Bay Hospital
Hastings, New Zealand
Palmerston North Hospital
Palmerston North, New Zealand
North Shore Hospital
Takapuna, New Zealand
Wellington Hospital
Wellington South, New Zealand
KRL University
Islamabad, Pakistan
Pakistan Institute of Medical Sciences
Islamabad, Pakistan
DUHS - Civil Hospital
Karachi, Pakistan
DUHS - Jinnah Hospital
Karachi, Pakistan
POF Hospital Wah Cantt.
Wah Cantt, Pakistan
Cagayan de Oro Medical Center
Cebu City, Philippines
Cebu Doctor's Hospital
Cebu City, Philippines
Cebu Velez General Hospital/ Visayas Comm. Medical Center
Cebu City, Philippines
Chong Hua Hospital
Cebu City, Philippines
Vicente Sotto Memorial Hospital
Cebu City, Philippines
Cagayan Valley Medical Center
East Santiago City, Philippines
Jose R Reyes Memorial Medical Centre
Manila, Philippines
University Santo Tomas Hospital
Manila, Philippines
Hospital Visconde de Salreu
Estarreja, Portugal
Hospital de Santa Maria
Lisbon, Portugal
Hospital Distrital de Oliverira de Azemeis
Oliveira de Azeméis, Portugal
Hospital Geral de Santo Antonio
Porto, Portugal
University of Novi Sad - Neurology & Neurosurgery
Novisad, Serbia
Singapore General Hospital
Singapore, Singapore
National Hospital of Sri Lanka
Colombo, Sri Lanka
University of Kelaniya
Ragama, Sri Lanka
University Hospital of North Staffordshire
Stoke-on-Trent, Shaffordshire, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Redbridge Health Care
Barking, United Kingdom
Barnsley District Hospital
Barnsley, United Kingdom
The Royal Victoria Hospital
Belfast, United Kingdom
Bronglais General Hospital
Ceredigion, United Kingdom
Western General Hospital, Edinburgh
Edinburgh, United Kingdom
Royal Devon & Exeter Hospital
Exeter, United Kingdom
Western Infirmary
Glasgow, United Kingdom
St Luke's Hospital
Huddersfield, United Kingdom
William Harvey Hospital
Kent, United Kingdom
University Hospital Aintree
Liverpool, United Kingdom
Altnagelvin Hospital
Londonderry, United Kingdom
Luton and Dunstable Hospital
Luton, United Kingdom
Royal Victoria Infirmary, Newcastle
Newcastle, United Kingdom
North Tyneside District General Hospital
North Shields, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
St Mary's Paddington Hospital
Paddington, United Kingdom
Rotherham General Hospital
Rotherham, United Kingdom
Stirling Royal Infirmary
Stirling, United Kingdom
Stepping Hill Hospital
Stockport, United Kingdom
Musgrove Park Hosptial
Taunton, United Kingdom
Torbay Hospital
Torquay, United Kingdom
Related Publications (8)
Gommans J, Yi Q, Eikelboom JW, Hankey GJ, Chen C, Rodgers H; VITATOPS trial study group. The effect of homocysteine-lowering with B-vitamins on osteoporotic fractures in patients with cerebrovascular disease: substudy of VITATOPS, a randomised placebo-controlled trial. BMC Geriatr. 2013 Sep 3;13:88. doi: 10.1186/1471-2318-13-88.
PMID: 24004645DERIVEDHankey GJ, Ford AH, Yi Q, Eikelboom JW, Lees KR, Chen C, Xavier D, Navarro JC, Ranawaka UK, Uddin W, Ricci S, Gommans J, Schmidt R, Almeida OP, van Bockxmeer FM; VITATOPS Trial Study Group. Effect of B vitamins and lowering homocysteine on cognitive impairment in patients with previous stroke or transient ischemic attack: a prespecified secondary analysis of a randomized, placebo-controlled trial and meta-analysis. Stroke. 2013 Aug;44(8):2232-9. doi: 10.1161/STROKEAHA.113.001886. Epub 2013 Jun 13.
PMID: 23765945DERIVEDCavalieri M, Schmidt R, Chen C, Mok V, de Freitas GR, Song S, Yi Q, Ropele S, Grazer A, Homayoon N, Enzinger C, Loh K, Wong KS, Wong A, Xiong Y, Chang HM, Wong MC, Fazekas F, Eikelboom JW, Hankey GJ; VITATOPS Trial Study Group. B vitamins and magnetic resonance imaging-detected ischemic brain lesions in patients with recent transient ischemic attack or stroke: the VITAmins TO Prevent Stroke (VITATOPS) MRI-substudy. Stroke. 2012 Dec;43(12):3266-70. doi: 10.1161/STROKEAHA.112.665703. Epub 2012 Oct 23.
PMID: 23093615DERIVEDHankey GJ, Eikelboom JW, Yi Q, Lees KR, Chen C, Xavier D, Navarro JC, Ranawaka UK, Uddin W, Ricci S, Gommans J, Schmidt R; VITATOPS trial study group. Antiplatelet therapy and the effects of B vitamins in patients with previous stroke or transient ischaemic attack: a post-hoc subanalysis of VITATOPS, a randomised, placebo-controlled trial. Lancet Neurol. 2012 Jun;11(6):512-20. doi: 10.1016/S1474-4422(12)70091-1. Epub 2012 May 2.
PMID: 22554931DERIVEDHankey GJ, Eikelboom JW, Yi Q, Lees KR, Chen C, Xavier D, Navarro JC, Ranawaka UK, Uddin W, Ricci S, Gommans J, Schmidt R; VITAmins TO Prevent Stroke (VITATOPS) Trial Study Group. Treatment with B vitamins and incidence of cancer in patients with previous stroke or transient ischemic attack: results of a randomized placebo-controlled trial. Stroke. 2012 Jun;43(6):1572-7. doi: 10.1161/STROKEAHA.111.641613. Epub 2012 Apr 3.
PMID: 22474057DERIVEDAlmeida OP, Marsh K, Alfonso H, Flicker L, Davis TM, Hankey GJ. B-vitamins reduce the long-term risk of depression after stroke: The VITATOPS-DEP trial. Ann Neurol. 2010 Oct;68(4):503-10. doi: 10.1002/ana.22189.
PMID: 20976769DERIVEDVITATOPS Trial Study Group. B vitamins in patients with recent transient ischaemic attack or stroke in the VITAmins TO Prevent Stroke (VITATOPS) trial: a randomised, double-blind, parallel, placebo-controlled trial. Lancet Neurol. 2010 Sep;9(9):855-65. doi: 10.1016/S1474-4422(10)70187-3. Epub 2010 Aug 3.
PMID: 20688574DERIVEDVITATOPS Trial Study Group; Hankey GJ, Algra A, Chen C, Wong MC, Cheung R, Wong L, Divjak I, Ferro J, de Freitas G, Gommans J, Groppa S, Hill M, Spence D, Lees K, Lisheng L, Navarro J, Ranawaka U, Ricci S, Schmidt R, Slivka A, Tan K, Tsiskaridze A, Uddin W, Vanhooren G, Xavier D, Armitage J, Hobbs M, Le M, Sudlow C, Wheatley K, Yi Q, Bulder M, Eikelboom JW, Hankey GJ, Ho WK, Jamrozik K, Klijn K, Koedam E, Langton P, Nijboer E, Tuch P, Pizzi J, Tang M, Antenucci M, Chew Y, Chinnery D, Cockayne C, Loh K, McMullin L, Smith F, Schmidt R, Chen C, Wong MC, de Freitas G, Hankey GJ, Loh K, Song S. VITATOPS, the VITAmins TO prevent stroke trial: rationale and design of a randomised trial of B-vitamin therapy in patients with recent transient ischaemic attack or stroke (NCT00097669) (ISRCTN74743444). Int J Stroke. 2007 May;2(2):144-50. doi: 10.1111/j.1747-4949.2007.00111.x.
PMID: 18705976DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Coordinator
- Organization
- VITATOPS
Study Officials
- PRINCIPAL INVESTIGATOR
Graeme Hankey, MBBS/MD
Royal Perth Hospital / University of Western Australia
- STUDY DIRECTOR
Ross Baker, MBBS/BMedSc
Royal Perth Hospital
- STUDY DIRECTOR
John Eikelboom, MBBS/FRACP
Royal Perth Hospital
- STUDY DIRECTOR
Konrad Jamrozik, MBBS
The University of Queensland
- STUDY DIRECTOR
Frank van Bockxmeer, BSc/PhD
Royal Perth Hospital
- STUDY DIRECTOR
Siobhan Hickling, BSc/MPH
The University of Western Australia
- STUDY DIRECTOR
Anna Gelavis, BPharm
Royal Perth Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2004
First Posted
November 25, 2004
Study Start
November 1, 1998
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
September 25, 2020
Results First Posted
September 25, 2020
Record last verified: 2014-01