Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - 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

Other interventions: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
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
Country [17] 0 0
India
State/province [17] 0 0
Indore
Country [18] 0 0
India
State/province [18] 0 0
Jaipur
Country [19] 0 0
India
State/province [19] 0 0
Kolkata
Country [20] 0 0
India
State/province [20] 0 0
Lucknow
Country [21] 0 0
India
State/province [21] 0 0
Ludhiana
Country [22] 0 0
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
Country [26] 0 0
India
State/province [26] 0 0
Trichy
Country [27] 0 0
India
State/province [27] 0 0
Visakhapatnam
Country [28] 0 0
India
State/province [28] 0 0
Wardha
Country [29] 0 0
Italy
State/province [29] 0 0
Brescia
Country [30] 0 0
Italy
State/province [30] 0 0
Busto Arsizio
Country [31] 0 0
Italy
State/province [31] 0 0
Macerata
Country [32] 0 0
Italy
State/province [32] 0 0
Pavia
Country [33] 0 0
Italy
State/province [33] 0 0
Perugia
Country [34] 0 0
Italy
State/province [34] 0 0
Vittoria
Country [35] 0 0
Malaysia
State/province [35] 0 0
Kelantan
Country [36] 0 0
Malaysia
State/province [36] 0 0
Kuala Lumpur
Country [37] 0 0
Moldova, Republic of
State/province [37] 0 0
Chishinau
Country [38] 0 0
Netherlands
State/province [38] 0 0
Amsterdam
Country [39] 0 0
Netherlands
State/province [39] 0 0
Goes
Country [40] 0 0
Netherlands
State/province [40] 0 0
Utrecht
Country [41] 0 0
New Zealand
State/province [41] 0 0
Auckland
Country [42] 0 0
New Zealand
State/province [42] 0 0
Hastings
Country [43] 0 0
New Zealand
State/province [43] 0 0
Palmerston North
Country [44] 0 0
New Zealand
State/province [44] 0 0
Takapuna
Country [45] 0 0
New Zealand
State/province [45] 0 0
Wellington South
Country [46] 0 0
Pakistan
State/province [46] 0 0
Islamabad
Country [47] 0 0
Pakistan
State/province [47] 0 0
Karachi
Country [48] 0 0
Pakistan
State/province [48] 0 0
Wah Cantt
Country [49] 0 0
Philippines
State/province [49] 0 0
Cebu City
Country [50] 0 0
Philippines
State/province [50] 0 0
East Santiago City
Country [51] 0 0
Philippines
State/province [51] 0 0
Manila
Country [52] 0 0
Portugal
State/province [52] 0 0
Estarreja
Country [53] 0 0
Portugal
State/province [53] 0 0
Lisboa
Country [54] 0 0
Portugal
State/province [54] 0 0
Oliveira de Azemeis
Country [55] 0 0
Portugal
State/province [55] 0 0
Porto
Country [56] 0 0
Serbia
State/province [56] 0 0
Novisad
Country [57] 0 0
Singapore
State/province [57] 0 0
Singapore
Country [58] 0 0
Sri Lanka
State/province [58] 0 0
Colombo
Country [59] 0 0
Sri Lanka
State/province [59] 0 0
Ragama
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Shaffordshire
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Aberdeen
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Barking
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Barnsley
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Belfast
Country [65] 0 0
United Kingdom
State/province [65] 0 0
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
State/province [75] 0 0
North Shields
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Nottingham
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Paddington
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Rotherham
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Stirling
Country [80] 0 0
United Kingdom
State/province [80] 0 0
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
Other
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00097669
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00097669