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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00097669




Registration number
NCT00097669
Ethics application status
Date submitted
24/11/2004
Date registered
25/11/2004
Date last updated
25/09/2020

Titles & IDs
Public title
VITATOPS: A Study of VITAmins TO Prevent Stroke
Scientific title
VITATOPS - A Study of VITAmins TO Prevent Stroke
Secondary ID [1] 0 0
ec550
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Transient Ischemic Attack 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo

Active comparator: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) - Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.

Placebo comparator: Placebo Tablet - 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.


Treatment: Drugs: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo
multivitamin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes
Timepoint [1] 0 0
The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
8164
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Central Coast Neuroscience Research - Gosford
Recruitment hospital [2] 0 0
Bankstown Hospital - New South Wales
Recruitment hospital [3] 0 0
John Hunter Hospital - New South Wales
Recruitment hospital [4] 0 0
Liverpool Hospital - New South Wales
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [6] 0 0
Greenslopes Hospital - Queensland
Recruitment hospital [7] 0 0
Nambour Hospital - Queensland
Recruitment hospital [8] 0 0
Flinders & Griffiths - South Australia
Recruitment hospital [9] 0 0
Royal Hobart Hospital - Tasmania
Recruitment hospital [10] 0 0
Alfred Hospital - Victoria
Recruitment hospital [11] 0 0
Beleura & Frankston Hospital - Victoria
Recruitment hospital [12] 0 0
Box Hill Hospital - Victoria
Recruitment hospital [13] 0 0
National Stroke Research Institute - Austin Health - Victoria
Recruitment hospital [14] 0 0
Fremantle Hospital - Western Australia
Recruitment hospital [15] 0 0
Joondalup Hospital - Western Australia
Recruitment hospital [16] 0 0
Sir Charles Gairdner Hospital - Western Australia
Recruitment postcode(s) [1] 0 0
- Gosford
Recruitment postcode(s) [2] 0 0
- New South Wales
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- Queensland
Recruitment postcode(s) [5] 0 0
- South Australia
Recruitment postcode(s) [6] 0 0
- Tasmania
Recruitment postcode(s) [7] 0 0
- Victoria
Recruitment postcode(s) [8] 0 0
- Western Australia
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
South Carolina
Country [4] 0 0
Austria
State/province [4] 0 0
Graz
Country [5] 0 0
Belgium
State/province [5] 0 0
Brugge
Country [6] 0 0
Brazil
State/province [6] 0 0
Rio de Janeiro
Country [7] 0 0
Georgia
State/province [7] 0 0
Tbilisi
Country [8] 0 0
Hong Kong
State/province [8] 0 0
Pokfulam
Country [9] 0 0
Hong Kong
State/province [9] 0 0
Shatin
Country [10] 0 0
India
State/province [10] 0 0
Annamalainagar
Country [11] 0 0
India
State/province [11] 0 0
Bangalore
Country [12] 0 0
India
State/province [12] 0 0
Bikaner
Country [13] 0 0
India
State/province [13] 0 0
Calicut
Country [14] 0 0
India
State/province [14] 0 0
Chennai
Country [15] 0 0
India
State/province [15] 0 0
Cochin
Country [16] 0 0
India
State/province [16] 0 0
Hyderabad
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India
State/province [17] 0 0
Indore
Country [18] 0 0
India
State/province [18] 0 0
Jaipur
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India
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Kolkata
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India
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Lucknow
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India
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Ludhiana
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India
State/province [22] 0 0
New Delhi
Country [23] 0 0
India
State/province [23] 0 0
Patiaala
Country [24] 0 0
India
State/province [24] 0 0
Perambur
Country [25] 0 0
India
State/province [25] 0 0
Pune
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India
State/province [26] 0 0
Trichy
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India
State/province [27] 0 0
Visakhapatnam
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India
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Wardha
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Italy
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Brescia
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Italy
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Busto Arsizio
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Italy
State/province [31] 0 0
Macerata
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Italy
State/province [32] 0 0
Pavia
Country [33] 0 0
Italy
State/province [33] 0 0
Perugia
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Italy
State/province [34] 0 0
Vittoria
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Malaysia
State/province [35] 0 0
Kelantan
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Malaysia
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Kuala Lumpur
Country [37] 0 0
Moldova, Republic of
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Chishinau
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Netherlands
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Amsterdam
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Netherlands
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Goes
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Netherlands
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Utrecht
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New Zealand
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Auckland
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New Zealand
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Hastings
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New Zealand
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Palmerston North
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New Zealand
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Takapuna
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New Zealand
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Wellington South
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Pakistan
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Islamabad
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Pakistan
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Karachi
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Pakistan
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Wah Cantt
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Philippines
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Cebu City
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Philippines
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East Santiago City
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Philippines
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Manila
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Portugal
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Estarreja
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Portugal
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Lisboa
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Portugal
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Oliveira de Azemeis
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Portugal
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Porto
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Serbia
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Novisad
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Singapore
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Singapore
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Sri Lanka
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Colombo
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Sri Lanka
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Ragama
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Shaffordshire
Country [61] 0 0
United Kingdom
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Aberdeen
Country [62] 0 0
United Kingdom
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Barking
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United Kingdom
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Barnsley
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Belfast
Country [65] 0 0
United Kingdom
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Ceredigion
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Edinburgh
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Exeter
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Glasgow
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Huddersfield
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Kent
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Liverpool
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Londonderry
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Luton
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Newcastle
Country [75] 0 0
United Kingdom
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North Shields
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United Kingdom
State/province [76] 0 0
Nottingham
Country [77] 0 0
United Kingdom
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Paddington
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United Kingdom
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Rotherham
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United Kingdom
State/province [79] 0 0
Stirling
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United Kingdom
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Stockport
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Taunton
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Torquay

Funding & Sponsors
Primary sponsor type
Government body
Name
VITATOPS
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Heart Foundation, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Medical Health Research Infrastructure Council, Australia
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Graeme Hankey, MBBS/MD
Address 0 0
Royal Perth Hospital / University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00097669