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ISRCTN
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ISRCTN74743444
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ClinicalTrials.gov identifier
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NCT00097669
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Public title
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A multi-centre, randomised, double-blind, placebo controlled clinical trial examining the efficiency and safety of multi-vitamin therapy in secondary stroke prevention
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Scientific title
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Acronym
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VITATOPS
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Serial number at source
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G0200583
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Study hypothesis
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To determine whether the addition of vitamin supplement (folate 2 mg, B6 25 mg, B12 500 µg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial infraction) and vascular death in patients with recent stroke or transient ischaemic attach (TIA).
Secondary objectives:
1. To determine whether the addition of vitamin supplements (folate 2 mg, B6 25 mg, B12 500 µg) will reduce:
a) The incidence of revascularisation procedures of the coronary, cerebral and peripheral circulations
b) Incidence of dementia and depression in patient with recent stroke or TIA
c) Occurrence of TIA in patients with recent stroke or TIA
2. To determine whether the effect of adding vitamin supplements (folate 2 mg, B6 25 mg, B12 500 µg) on the incidence of the primary outcome event (stroke, MI or vascular death) is consistent in patient subgroups such as those of different ethnicity and genotype.
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Ethics approval
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Not provided at time of registration
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Study design
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Multicentre randomised double-blind placebo controlled clinical
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Countries of recruitment
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United Kingdom, International
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Disease/condition/study domain
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Cardiovascular
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Participants - inclusion criteria
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All patients presenting to one of the participating neurologists or general physicians within 7 months of stroke (ischaemic or haemorrhagic) or transient ischemic attack (TIA) (eye or brain) are eligible for this trial.
In addition the patient must:
1. Agree to take study medications
2. Be geographically accessible for follow up
3. Provide written informed consent
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Participants - exclusion criteria
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1. Taking folate or vitamin B6, on medical advice
2. Use of vitamin supplements containing B6, B12 or Folate (unless patient agrees to take study medication instead of the vitamin supplements which they usually take)
3. Taking Methotrexate for any reason
4. Pregnancy or women of child-bearing potential who are at risk of pregnancy
5. Limited life expectancy
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Anticipated start date
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01/07/2003
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Anticipated end date
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31/07/2010
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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8000
Added 07/07/09: UK sample size is 1000 patients.
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Interventions
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Multivitamins folate 2 mg, B6 25 mg, B12 500 µg or placebo
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Primary outcome measure(s)
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The primary outcome event is the composite event 'stroke, myocardial infarction, or death from any vascular cause', whichever occurs first.
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Secondary outcome measure(s)
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Secondary outcome measures include TIA, depression, dementia, unstable angina, revascularisation procedures of the coronary, cerebral and peripheral circulations.
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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2002 protocol in http://www.ncbi.nlm.nih.gov/pubmed/11867886
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Contact name
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Prof
Kennedy R
Lees
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Address
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Department of Medicine & Therapeutics
Gardiner Institute
Western Infirmary
44 Church Street
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City/town
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Glasgow
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Zip/Postcode
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G11 6NT
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Country
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United Kingdom
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Email
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krl1r@clinmed.gla.ac.uk
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Sponsor
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University of Glasgow and Greater Glasgow Health Board (UK)
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Address
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University of Glasgow
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City/town
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Glasgow
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Zip/Postcode
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G12 8QQ
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Country
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United Kingdom
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Tel
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+44 (0)141 330 2000
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Email
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Sponsor website:
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http://www.gla.ac.uk/
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Date applied
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22/05/2003
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Last edited
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07/09/2009
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Date ISRCTN assigned
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22/05/2003
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