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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN74743444 |
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Date of registration:
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22/05/2003 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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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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Date of first enrolment:
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01/07/2003 |
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Target sample size:
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8000 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN74743444 |
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Study type:
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Interventional |
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Study design:
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Multicentre randomised double-blind placebo-controlled clinical (Not Specified)
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Phase:
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Countries of recruitment
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Australia
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Austria
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Belgium
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Brazil
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Georgia
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Hong Kong
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India
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Italy
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Malaysia
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Moldova
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Netherlands
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New Zealand
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Pakistan
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Philippines
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Portugal
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Serbia
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Singapore
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Sri Lanka
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United Kingdom
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United States of America
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Kennedy R
Lees |
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Address:
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Department of Medicine & Therapeutics
Gardiner Institute
Western Infirmary
44 Church Street
G11 6NT
Glasgow
United Kingdom |
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Telephone:
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Email:
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krl1r@clinmed.gla.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: 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
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Cardiovascular
Circulatory System
Stroke
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Intervention(s)
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Multivitamins folate 2 mg, B6 25 mg, B12 500 µg or placebo
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Primary Outcome(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(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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Secondary ID(s)
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G0200583
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NCT00097669
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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