Plain English Summary

Not provided at time of registration

Trial website

http://vitatops.highway1.com.au/index.htm

Contact information

Type

Scientific

Primary contact

Prof Kennedy R Lees

ORCID ID

Contact details

Department of Medicine & Therapeutics
Gardiner Institute
Western Infirmary
44 Church Street
Glasgow
G11 6NT
United Kingdom
krl1r@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00097669

Protocol/serial number

G0200583

Study information

Scientific title

Acronym

VITATOPS

Study hypothesis

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.

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised double-blind placebo-controlled clinical

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Patient information can be found at: http://vitatops.highway1.com.au/html/index.asp?section=gen

Condition

Cardiovascular

Intervention

Multivitamins folate 2 mg, B6 25 mg, B12 500 µg or placebo

Intervention type

Supplement

Phase

Not Specified

Drug names

Multivitamins folate, B6, B12

Primary outcome measures

The primary outcome event is the composite event 'stroke, myocardial infarction, or death from any vascular cause', whichever occurs first.

Secondary outcome measures

Secondary outcome measures include TIA, depression, dementia, unstable angina, revascularisation procedures of the coronary, cerebral and peripheral circulations.

Overall trial start date

01/07/2003

Overall trial end date

31/07/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

8000
Added 07/07/2009: UK sample size is 1000 patients.

Participant 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

Recruitment start date

01/07/2003

Recruitment end date

31/07/2010

Locations

Countries of recruitment

Australia, Austria, Belgium, Brazil, Georgia, Hong Kong, India, Italy, Malaysia, Moldova, Netherlands, New Zealand, Pakistan, Philippines, Portugal, Serbia, Singapore, Sri Lanka, United Kingdom, United States of America

Trial participating centre

Department of Medicine & Therapeutics
Glasgow
G11 6NT
United Kingdom

Sponsor information

Organisation

University of Glasgow and Greater Glasgow Health Board (UK)

Sponsor details

University of Glasgow
Glasgow
G12 8QQ
United Kingdom
+44 (0)141 330 2000

Sponsor type

Not defined

Website

http://www.gla.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2002 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/11867886
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20688574
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22554931
2012 cancer sub-study results in: http://www.ncbi.nlm.nih.gov/pubmed/22474057
2012 MRI sub-study results in: http://www.ncbi.nlm.nih.gov/pubmed/23093615
2013 osteoporotic fractures sub-study results in: http://www.ncbi.nlm.nih.gov/pubmed/24004645
2013 secondary analysis in: http://www.ncbi.nlm.nih.gov/pubmed/23765945

Publication citations

  1. Protocol

    The VITATOPS (Vitamins to Prevent Stroke) Trial: rationale and design of an international, large, simple, randomised trial of homocysteine-lowering multivitamin therapy in patients with recent transient ischaemic attack or stroke., Cerebrovasc. Dis., 2002, 13, 2, 120-126.

  2. Results

    B vitamins in patients with recent transient ischaemic attack or stroke in the VITAmins TO Prevent Stroke (VITATOPS) trial: a randomised, double-blind, parallel, placebo-controlled trial., Lancet Neurol, 2010, 9, 9, 855-865, doi: 10.1016/S1474-4422(10)70187-3.

  3. Results

    Hankey GJ, Eikelboom JW, Yi Q, Lees KR, Chen C, Xavier D, Navarro JC, Ranawaka UK, Uddin W, Ricci S, Gommans J, Schmidt R, , Antiplatelet therapy and the effects of B vitamins in patients with previous stroke or transient ischaemic attack: a post-hoc subanalysis of VITATOPS, a randomised, placebo-controlled trial., Lancet Neurol, 2012, 11, 6, 512-520, doi: 10.1016/S1474-4422(12)70091-1.

  4. Secondary analysis

    Hankey GJ, Ford AH, Yi Q, Eikelboom JW, Lees KR, Chen C, Xavier D, Navarro JC, Ranawaka UK, Uddin W, Ricci S, Gommans J, Schmidt R, Almeida OP, van Bockxmeer FM, , Effect of B vitamins and lowering homocysteine on cognitive impairment in patients with previous stroke or transient ischemic attack: a prespecified secondary analysis of a randomized, placebo-controlled trial and meta-analysis., Stroke, 2013, 44, 8, 2232-2239, doi: 10.1161/STROKEAHA.113.001886.

  5. Hankey GJ, Eikelboom JW, Yi Q, Lees KR, Chen C, Xavier D, Navarro JC, Ranawaka UK, Uddin W, Ricci S, Gommans J, Schmidt R, , Treatment with B vitamins and incidence of cancer in patients with previous stroke or transient ischemic attack: results of a randomized placebo-controlled trial., Stroke, 2012, 43, 6, 1572-1577, doi: 10.1161/STROKEAHA.111.641613.

  6. Cavalieri M, Schmidt R, Chen C, Mok V, de Freitas GR, Song S, Yi Q, Ropele S, Grazer A, Homayoon N, Enzinger C, Loh K, Wong KS, Wong A, Xiong Y, Chang HM, Wong MC, Fazekas F, Eikelboom JW, Hankey GJ, , B vitamins and magnetic resonance imaging-detected ischemic brain lesions in patients with recent transient ischemic attack or stroke: the VITAmins TO Prevent Stroke (VITATOPS) MRI-substudy., Stroke, 2012, 43, 12, 3266-3270, doi: 10.1161/STROKEAHA.112.665703.

  7. Gommans J, Yi Q, Eikelboom JW, Hankey GJ, Chen C, Rodgers H, , The effect of homocysteine-lowering with B-vitamins on osteoporotic fractures in patients with cerebrovascular disease: substudy of VITATOPS, a randomised placebo-controlled trial., BMC Geriatr, 2013, 13, 88, doi: 10.1186/1471-2318-13-88.

Editorial Notes