StrokeNCT00097669
VITATOPS: A Study of VITAmins TO Prevent Stroke
A study of Stroke and Transient Ischemic Attack, run by VITATOPS at 111 sites in 20 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,164 participants
- Where
- 111 sitesin 20 countries
- Study dates
- Nov 1998to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
111 sites in 20 countries.
111 sites in 20 countries
India23 sites
Rajah Muthaiah Medical College
Annāmalainagar
St John's Medical College Hospital
Bangalore
SP Medical College
Bikaner
Baby Memorial Hospital
Calicut
KS Hospital
Chennai
Care Hopstial
Hyderabad
Mahaveer Hospital & Research Centre
Hyderabad
Mediciti Hospital
Hyderabad
MGM Medical College & MY Hospital
Indore
Monilek Hospital
Jaipur
Amrita Institute of Medical Science
Kochi
Centauri, The Albert Road Clinic
Kolkata
CSMMU
Lucknow
Christian Medical College & Hospital
Ludhiana
G.B. Pant Hospital
New Delhi
Sir Ganga Ram Hospital
New Delhi
Sadhbavana Medical & Heart Institute
Patiaala
Railway Hospital
Perambūr
Poona Hospital
Pune
Ruby Hall Clinic
Pune
Neurocenter
Trichy
Care Hospital
Visakhapatnam
Mahatma Gandhi Institute
Wardha
United Kingdom23 sites
Aberdeen Royal Infirmary
Aberdeen
Redbridge Health Care
Barking
Barnsley District Hospital
Barnsley
The Royal Victoria Hospital
Belfast
Bronglais General Hospital
Ceredigion
Western General Hospital, Edinburgh
Edinburgh
Royal Devon & Exeter Hospital
Exeter
Western Infirmary
Glasgow
St Luke's Hospital
Huddersfield
William Harvey Hospital
Kent
University Hospital Aintree
Liverpool
Altnagelvin Hospital
Londonderry
Luton and Dunstable Hospital
Luton
Royal Victoria Infirmary, Newcastle
Newcastle
North Tyneside District General Hospital
North Shields
Nottingham City Hospital
Nottingham
St Mary's Paddington Hospital
Paddington
Rotherham General Hospital
Rotherham
Stirling Royal Infirmary
Stirling
Stepping Hill Hospital
Stockport
University Hospital of North Staffordshire
Stoke-on-Trent, Shaffordshire
Musgrove Park Hosptial
Taunton
Torbay Hospital
Torquay
Australia16 sites
Central Coast Neuroscience Research
Gosford
Bankstown Hospital
New South Wales
John Hunter Hospital
New South Wales
Liverpool Hospital
New South Wales
Royal Perth Hospital
Perth
Greenslopes Hospital
Queensland
Nambour Hospital
Queensland
Flinders & Griffiths
South Australia
Royal Hobart Hospital
Tasmania
Alfred Hospital
Victoria
Beleura & Frankston Hospital
Victoria
Box Hill Hospital
Victoria
National Stroke Research Institute - Austin Health
Victoria
Fremantle Hospital
Western Australia
Joondalup Hospital
Western Australia
Sir Charles Gairdner Hospital
Western Australia
Philippines8 sites
Cagayan de Oro Medical Center
Cebu City
Cebu Doctor's Hospital
Cebu City
Cebu Velez General Hospital/ Visayas Comm. Medical Center
Cebu City
Chong Hua Hospital
Cebu City
Vicente Sotto Memorial Hospital
Cebu City
Cagayan Valley Medical Center
East Santiago City
Jose R Reyes Memorial Medical Centre
Manila
University Santo Tomas Hospital
Manila
Italy7 sites
Spedali Civili Di Brescia
Brescia
Ospedale di Circolo de Busto Arsizio
Busto Arsizio
IRCCS Fondazione Istituto Neurologico C Mondino
Pavia
Perugia Stroke Service & Citta Della Peive
Perugia
University of Perugia
Perugia
Ospedale di Macerata
Province of Macerata
Ospedale R Guzzardi
Vittoria
New Zealand5 sites
Auckland Hospital
Auckland
Hawkes Bay Hospital
Hastings
Palmerston North Hospital
Palmerston North
North Shore Hospital
Takapuna
Wellington Hospital
Wellington South
Pakistan5 sites
KRL University
Islamabad
Pakistan Institute of Medical Sciences
Islamabad
DUHS - Civil Hospital
Karachi
DUHS - Jinnah Hospital
Karachi
POF Hospital Wah Cantt.
Wah Cantt
United States4 sites
Abington Memorial Hospital
Abington, Pennsylvania
South Carolina VA Hospital
Columbia, South Carolina
University of South Carolina
Columbia, South Carolina
JFK Hospital / Seton Hall University
New York, New York
Portugal4 sites
Hospital Visconde de Salreu
Estarreja
Hospital de Santa Maria
Lisbon
Hospital Distrital de Oliverira de Azemeis
Oliveira de Azeméis
Hospital Geral de Santo Antonio
Porto
Netherlands3 sites
Slotervaartziekenhuis
Amsterdam
Oosterscheldeziekenhuis
Goes
University Medical Center Utrecht
Utrecht
Hong Kong2 sites
Queen Mary Hospital
Pokfulam
Prince of Wales Hospital
Shatin
Malaysia2 sites
Hospital Universiti Sains Malaysia
Kelantan
University of Malaya Medical Centre
Kuala Lumpur
Sri Lanka2 sites
National Hospital of Sri Lanka
Colombo
University of Kelaniya
Ragama
Belgium1 site
Algemeen Ziekenhuis Sint-Jan Autonome Verzorgingsinstelling
Bruges
Brazil1 site
Universidade Federal Fluminense & Universidade Federal do Rio de Janeiro
Rio de Janeiro
About this study
Official title: VITATOPS - A Study of VITAmins TO Prevent Stroke
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.
Read the detailed description
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.
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.
- Conditions
- Stroke, Transient Ischemic Attack
- Being tested
- Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo, Placebo
- Keywords
- VITATOPS, stroke, prevention, multivitamins, homocysteine
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placeboDrug
Also called VITATOPS study tablet
multivitamin
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) | Active comparator | Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study. Receives: Drug: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo |
| Placebo Tablet | Placebo comparator | Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes
Measured: The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2004 (estimated)
- Study startNov 1998
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8,164 participants (actual)
Sponsor and investigators
- Lead sponsor
- VITATOPS
- Sponsor type
- Other government
- Collaborators
- National Health and Medical Research Council, Australia, National Heart Foundation, Australia, Medical Health Research Infrastructure Council, Australia
- Responsible party
- Sponsor
- Investigators
- Graeme Hankey, MBBS/MD, Principal investigator, Royal Perth Hospital / University of Western AustraliaRoss Baker, MBBS/BMedSc, Study director, Royal Perth HospitalJohn Eikelboom, MBBS/FRACP, Study director, Royal Perth HospitalKonrad Jamrozik, MBBS, Study director, The University of QueenslandFrank van Bockxmeer, BSc/PhD, Study director, Royal Perth HospitalSiobhan Hickling, BSc/MPH, Study director, The University of Western AustraliaAnna Gelavis, BPharm, Study director, Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097669
- Sponsor's protocol ID
- ec550
- Status last verified
- Jan 2014
- First submitted
- 24 Nov 2004
- Last updated
- 25 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24004645Hankey 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.
PubMed 23765945Cavalieri 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.
PubMed 23093615Hankey 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.
PubMed 22554931Hankey 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.
PubMed 22474057Almeida 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.
PubMed 20976769VITATOPS 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.
PubMed 20688574VITATOPS 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.
PubMed 18705976
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VITATOPS - A Study of VITAmins TO Prevent Stroke
- ClinicalTrials.gov ID
- NCT00097669
- Acronym / sponsor ID
- ec550
- Conditions
- Stroke, Transient Ischemic Attack
- Keywords
- VITATOPS, stroke, prevention, multivitamins, homocysteine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,164 participants (actual)
- Lead sponsor
- VITATOPSOther government
- Collaborators
- National Health and Medical Research Council, Australia, National Heart Foundation, Australia, Medical Health Research Infrastructure Council, Australia
- Study start
- Nov 1998
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Nov 2004 (estimated)
- Results
- Posted 25 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) | Active comparator | Drug: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placeboActive 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 comparator | Other: PlaceboPlacebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placeboAlso: VITATOPS study tabletmultivitamin | Drug | Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) |
| Placebo | Other | Placebo Tablet |
Primary outcome
Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes
Time frame: The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24004645Gommans 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.
- Derived from this study: PubMed 23765945Hankey 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.
- Derived from this study: PubMed 23093615Cavalieri 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.
- Derived from this study: PubMed 22554931Hankey 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.
- Derived from this study: PubMed 22474057Hankey 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.
- Derived from this study: PubMed 20976769Almeida 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.
- Derived from this study: PubMed 20688574VITATOPS 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.
- Derived from this study: PubMed 18705976VITATOPS 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.
- National Heart FoundationLink provided by the sponsor.
- National Stroke FoundationLink provided by the sponsor.
- Stroke Society of Australasia Inc.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
111 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stroke and Transient Ischemic Attack, run by VITATOPS at 111 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 111 sites in India, United Kingdom, Australia, Philippines, Italy and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes (time frame: The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00097669, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.