A multi-centre, randomised, double-blind, placebo controlled clinical trial examining the efficiency and safety of multi-vitamin therapy in secondary stroke prevention

Conditions

Cardiovascular Circulatory System Stroke

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, VITATOPS Trial Study Group.

2013-06-1360 citations

10.1161/strokeaha.113.001886

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.

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, VITATOPS Trial Study Group.

2012-10-2360 citations

10.1161/strokeaha.112.665703

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.

Hankey GJ, Eikelboom JW, Yi Q, Lees KR, Chen C, Xavier D, Navarro JC, Ranawaka UK, Uddin W, Ricci S, Gommans J, Schmidt R, VITATOPS trial study group.

2012-05-0260 citations

10.1016/s1474-4422(12)70091-1

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.

VITATOPS Trial Study Group.

2010-08-03201 citations

10.1016/s1474-4422(10)70187-3

Interventions

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

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

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

Outcome results

None listed