VITATOPS: A Study of VITAmins TO Prevent Stroke
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/14/2017 |
| Start Date: | November 1998 |
| End Date: | June 2009 |
VITATOPS - A Study of VITAmins TO Prevent Stroke
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.
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.
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.
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.
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
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