Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097669
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2004-11-24
Brief Title:
VITATOPS A Study of VITAmins TO Prevent Stroke
Sponsor:
VITATOPS
Organization:
VITATOPS
Study Overview
Official Title:
VITATOPS - A Study of VITAmins TO Prevent Stroke
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 medicalsurgical 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 8000 patients over the next two years with a median follow-up of 25 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 68 per year with an alpha of 005 and power of 80 8000 patients need to be randomized and followed-up for an average of two years
Current progress As of November 2004 more than 4400 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 8000 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
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 68 per year with an alpha of 005 and power of 80 8000 patients need to be randomized and followed-up for an average of two years
Current progress As of November 2004 more than 4400 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 8000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None