VITATOPS: A Study of VITAmins TO Prevent Stroke

Not Applicable

Completed

Conditions: Stroke
Transient Ischemic Attack

Interventions: Drug: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo
Other: Placebo

Registration Number: NCT00097669

Lead Sponsor: VITATOPS

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8164

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug)	Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo	Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.
Placebo Tablet	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes	The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (111): JFK Hospital / Seton Hall University
🇺🇸
New York, New York, United States
Abington Memorial Hospital
🇺🇸
Abington, Pennsylvania, United States
South Carolina VA Hospital
🇺🇸
Columbia, South Carolina, United States
University of South Carolina
🇺🇸
Columbia, South Carolina, United States
Central Coast Neuroscience Research
🇦🇺
Gosford, Australia
Bankstown Hospital
🇦🇺
New South Wales, Australia
John Hunter Hospital
🇦🇺
New South Wales, Australia
Liverpool Hospital
🇦🇺
New South Wales, Australia
Royal Perth Hospital
🇦🇺
Perth, Australia
Greenslopes Hospital
🇦🇺
Queensland, Australia
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JFK Hospital / Seton Hall University
🇺🇸New York, New York, United States