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VITATOPS: A Study of VITAmins TO Prevent Stroke

This study has been completed.
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
National Heart Foundation, Australia
Medical Health Research Infrastructure Council, Australia
Information provided by:
VITATOPS
ClinicalTrials.gov Identifier:
NCT00097669
First received: November 24, 2004
Last updated: February 24, 2010
Last verified: February 2010
  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 Intervention
Stroke
Transient Ischemic Attack
Other: folic acid
Dietary Supplement: Vitamin B6
Dietary Supplement: Vitamin B12

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: VITATOPS - A Study of VITAmins TO Prevent Stroke

Resource links provided by NLM:


Further study details as provided by VITATOPS:

Primary Outcome Measures:
  • Non-fatal stroke [ Time Frame: trial end ] [ Designated as safety issue: Yes ]
  • Non-fatal myocardial infarction [ Time Frame: trial end ] [ Designated as safety issue: Yes ]
  • Death due to vascular causes [ Time Frame: trial end ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • TIA [ Time Frame: trial end ] [ Designated as safety issue: Yes ]
  • Revascularization procedures [ Time Frame: trial end ] [ Designated as safety issue: Yes ]
  • Dementia [ Time Frame: trial end ] [ Designated as safety issue: Yes ]
  • Depression [ Time Frame: trial end ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8000
Study Start Date: November 1998
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: folic acid
    2 mg
    Other Name: folate
    Dietary Supplement: Vitamin B6
    25mg
    Other Name: Pyridoxine
    Dietary Supplement: Vitamin B12
    500ug
    Other Name: Cyanocobalamin
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097669

  Hide Study Locations
Locations
United States, New York
JFK Hospital / Seton Hall University
New York, New York, United States
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States
United States, South Carolina
South Carolina VA Hospital
Columbia, South Carolina, United States
University of South Carolina
Columbia, South Carolina, United States
Australia
Central Coast Neuroscience Research
Gosford, Australia
Liverpool Hospital
New South Wales, Australia
John Hunter Hospital
New South Wales, Australia
Bankstown 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
Austria
Karl-Franzens University Graz
Graz, Austria
Belgium
Algemeen Ziekenhuis Sint-Jan Autonome Verzorgingsinstelling
Brugge, Belgium
Brazil
Universidade Federal Fluminense & Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil
Georgia
Sarajishvili Institute of Neurology and Neurosurgery
Tbilisi, Georgia
Hong Kong
Queen Mary Hospital
Pokfulam, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
India
Rajah Muthaiah Medical College
Annamalainagar, India
St John's Medical College Hospital
Bangalore, India
SP Medical College
Bikaner, India
Baby Memorial Hospital
Calicut, India
KS Hospital
Chennai, India
Amrita Institute of Medical Science
Cochin, 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
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
Perambur, India
Poona Hospital
Pune, India
Ruby Hall Clinic
Pune, India
Neurocenter
Trichy, India
Care Hospital
Visakhapatnam, India
Mahatma Gandhi Institute
Wardha, India
Italy
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
Malaysia
Hospital Universiti Sains Malaysia
Kelantan, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Malaysia
Moldova, Republic of
City Emergency Hospital
Chishinau, Moldova, Republic of
Netherlands
Slotervaartziekenhuis
Amsterdam, Netherlands
Oosterscheldeziekenhuis
Goes, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
New Zealand
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
Pakistan
Pakistan Institute of Medical Sciences
Islamabad, Pakistan
KRL University
Islamabad, Pakistan
DUHS - Civil Hospital
Karachi, Pakistan
DUHS - Jinnah Hospital
Karachi, Pakistan
POF Hospital Wah Cantt.
Wah Cantt, Pakistan
Philippines
Vicente Sotto Memorial Hospital
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
Cagayan de Oro Medical Center
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
Portugal
Hospital Visconde de Salreu
Estarreja, Portugal
Hospital de Santa Maria
Lisboa, Portugal
Hospital Distrital de Oliverira de Azemeis
Oliveira de Azemeis, Portugal
Hospital Geral de Santo Antonio
Porto, Portugal
Serbia
University of Novi Sad - Neurology & Neurosurgery
Novisad, Serbia
Singapore
Singapore General Hospital
Singapore, Singapore
Sri Lanka
National Hospital of Sri Lanka
Colombo, Sri Lanka
University of Kelaniya
Ragama, Sri Lanka
United Kingdom
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
Sponsors and Collaborators
VITATOPS
National Health and Medical Research Council, Australia
National Heart Foundation, Australia
Medical Health Research Infrastructure Council, Australia
Investigators
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
  More Information

Additional Information:
No publications provided by VITATOPS

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
VITATOPS 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.

Responsible Party: Professor Graeme Hankey, Royal Perth Hospital
ClinicalTrials.gov Identifier: NCT00097669     History of Changes
Other Study ID Numbers: ec550
Study First Received: November 24, 2004
Last Updated: February 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by VITATOPS:
VITATOPS
stroke
prevention
multivitamins
homocysteine

Additional relevant MeSH terms:
Cerebral Infarction
Ischemic Attack, Transient
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Vitamin B 12
Vitamin B Complex
Vitamins
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014