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VITATOPS: A Study of VITAmins TO Prevent Stroke

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00097669
Recruitment Status : Completed
First Posted : November 25, 2004
Results First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
National Heart Foundation, Australia
Medical Health Research Infrastructure Council, Australia
Information provided by (Responsible Party):
VITATOPS

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Transient Ischemic Attack Drug: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo Other: Placebo Not Applicable

Detailed Description:

Background: Epidemiological studies suggest that raised plasma concentrations of total homocysteine (tHcy) may be a common, causal and treatable risk factor for atherothromboembolic ischemic stroke, dementia and depression. Although tHcy can be lowered effectively with small doses of folic acid, vitamin B12 and vitamin B6, it is not known whether lowering tHcy, by means of multivitamin therapy, can prevent stroke and other major atherothromboembolic vascular events, dementia and depression.

Purpose: To determine whether vitamin supplements (folic acid 2 mg, B6 25 mg, B12 500 ug) reduce the risk of stroke, other serious vascular events, dementia and depression in patients with recent stroke or transient ischemic attacks of the brain or eye (TIA).

Methods: An international, multi-center, randomized, double-blind, placebo-controlled clinical trial.

Subjects: Patients with stroke or TIA in the previous 7 months.

Primary outcome measure: Non-fatal stroke, non-fatal myocardial infarction, or death due to vascular causes.

Secondary outcome measures: TIA, Revascularisation procedures, Dementia, Depression.

Sample size calculation: To reliably identify a 15% reduction in relative risk of the primary outcome event from 8% to 6.8% per year with an alpha of 0.05 and power of 80%, 8,000 patients need to be randomized and followed-up for an average of two years.

Current progress: As of November, 2004, more than 4,400 patients have been randomized in 73 centers in 19 countries in five continents: Australia, Austria, Belgium, Brazil, Hong Kong, Italy, Malaysia, Moldova, Netherlands, New Zealand, Pakistan, Philippines, Portugal, Republic of Georgia, Serbia & Monte Negro, Singapore, Sri Lanka, United Kingdom, and United States.

VITATOPS aims to recruit and follow up 8,000 patients between 2000 and 2006, and provide a reliable estimate of the safety and effectiveness of dietary supplementation with folic acid, vitamin B12, and vitamin B6 in reducing recurrent serious vascular events, dementia and depression among a wide range of patients with stroke and TIA.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: VITATOPS - A Study of VITAmins TO Prevent Stroke
Study Start Date : November 1998
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo
multivitamin
Other Name: VITATOPS study tablet
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.
 Other: Placebo


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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097669


Locations
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Sponsors and Collaborators
VITATOPS
National Health and Medical Research Council, Australia
National Heart Foundation, Australia
Medical Health Research Infrastructure Council, Australia
Investigators
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Principal Investigator: Graeme Hankey, MBBS/MD Royal Perth Hospital / University of Western Australia
Study Director: Ross Baker, MBBS/BMedSc Royal Perth Hospital
Study Director: John Eikelboom, MBBS/FRACP Royal Perth Hospital
Study Director: Konrad Jamrozik, MBBS The University of Queensland
Study Director: Frank van Bockxmeer, BSc/PhD Royal Perth Hospital
Study Director: Siobhan Hickling, BSc/MPH The University of Western Australia
Study Director: Anna Gelavis, BPharm Royal Perth Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
VITATOPS Trial Study Group, Hankey GJ, Algra A, Chen C, Wong MC, Cheung R, Wong L, Divjak I, Ferro J, de Freitas G, Gommans J, Groppa S, Hill M, Spence D, Lees K, Lisheng L, Navarro J, Ranawaka U, Ricci S, Schmidt R, Slivka A, Tan K, Tsiskaridze A, Uddin W, Vanhooren G, Xavier D, Armitage J, Hobbs M, Le M, Sudlow C, Wheatley K, Yi Q, Bulder M, Eikelboom JW, Hankey GJ, Ho WK, Jamrozik K, Klijn K, Koedam E, Langton P, Nijboer E, Tuch P, Pizzi J, Tang M, Antenucci M, Chew Y, Chinnery D, Cockayne C, Loh K, McMullin L, Smith F, Schmidt R, Chen C, Wong MC, de Freitas G, Hankey GJ, Loh K, Song S. VITATOPS, the VITAmins TO prevent stroke trial: rationale and design of a randomised trial of B-vitamin therapy in patients with recent transient ischaemic attack or stroke (NCT00097669) (ISRCTN74743444). Int J Stroke. 2007 May;2(2):144-50. doi: 10.1111/j.1747-4949.2007.00111.x.

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Responsible Party: VITATOPS
ClinicalTrials.gov Identifier: NCT00097669    
Other Study ID Numbers: ec550
First Posted: November 25, 2004    Key Record Dates
Results First Posted: September 25, 2020
Last Update Posted: September 25, 2020
Last Verified: January 2014
Keywords provided by VITATOPS:
VITATOPS
stroke
prevention
multivitamins
homocysteine
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Brain Ischemia
Folic Acid
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs