VITATOPS: A Study of VITAmins TO Prevent Stroke

This study has been completed.
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
National Heart Foundation, Australia
Medical Health Research Infrastructure Council, Australia
Information provided by:
VITATOPS
ClinicalTrials.gov Identifier:
NCT00097669
First received: November 24, 2004
Last updated: February 24, 2010
Last verified: February 2010
  Purpose

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 Intervention
Stroke
Transient Ischemic Attack
Other: folic acid
Dietary Supplement: Vitamin B6
Dietary Supplement: Vitamin B12

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: VITATOPS - A Study of VITAmins TO Prevent Stroke

Resource links provided by NLM:


Further study details as provided by VITATOPS:

Primary Outcome Measures:
  • Non-fatal stroke [ Time Frame: trial end ] [ Designated as safety issue: Yes ]
  • Non-fatal myocardial infarction [ Time Frame: trial end ] [ Designated as safety issue: Yes ]
  • Death due to vascular causes [ Time Frame: trial end ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • TIA [ Time Frame: trial end ] [ Designated as safety issue: Yes ]
  • Revascularization procedures [ Time Frame: trial end ] [ Designated as safety issue: Yes ]
  • Dementia [ Time Frame: trial end ] [ Designated as safety issue: Yes ]
  • Depression [ Time Frame: trial end ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8000
Study Start Date: November 1998
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: folic acid
    2 mg
    Other Name: folate
    Dietary Supplement: Vitamin B6
    25mg
    Other Name: Pyridoxine
    Dietary Supplement: Vitamin B12
    500ug
    Other Name: Cyanocobalamin
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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097669

  Show 111 Study Locations
Sponsors and Collaborators
VITATOPS
National Health and Medical Research Council, Australia
National Heart Foundation, Australia
Medical Health Research Infrastructure Council, Australia
Investigators
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

Additional Information:
No publications provided by VITATOPS

Additional 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.

Responsible Party: Professor Graeme Hankey, Royal Perth Hospital
ClinicalTrials.gov Identifier: NCT00097669     History of Changes
Other Study ID Numbers: ec550
Study First Received: November 24, 2004
Last Updated: February 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by VITATOPS:
VITATOPS
stroke
prevention
multivitamins
homocysteine

Additional relevant MeSH terms:
Ischemic Attack, Transient
Stroke
Cerebral Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Folic Acid
Hydroxocobalamin
Vitamin B Complex
Vitamin B 12
Pyridoxine
Vitamin B 6
Pyridoxal
Vitamins
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014