VITATOPS: A Study of VITAmins TO Prevent Stroke
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|ClinicalTrials.gov Identifier: NCT00097669|
Recruitment Status : Completed
First Posted : November 25, 2004
Results First Posted : September 25, 2020
Last Update Posted : September 25, 2020
|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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
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.
- 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). ]
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
|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|