VITATOPS: A Study of VITAmins TO Prevent Stroke
Keywords
Coimriú
Cur síos
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.
Dátaí
| Fíoraithe Deireanach: | 12/31/2013 |
| Cuireadh isteach den chéad uair: | 11/23/2004 |
| Clárú Measta Curtha isteach: | 11/23/2004 |
| Arna chur suas ar dtús: | 11/24/2004 |
| Nuashonrú Deireanach Curtha isteach: | 09/06/2020 |
| Nuashonrú Deireanach Postáilte: | 09/24/2020 |
| Dáta na gcéad torthaí a cuireadh isteach: | 01/19/2014 |
| Dáta na dtorthaí QC a cuireadh isteach den chéad uair: | 09/06/2020 |
| Dáta na gcéad torthaí a cuireadh sa phost: | 09/24/2020 |
| Dáta Tosaigh an Staidéir Iarbhír: | 10/31/1998 |
| Dáta Críochnaithe Bunscoile Measta: | 05/31/2009 |
| Dáta Críochnaithe an Staid Mheasta: | 05/31/2009 |
Coinníoll nó galar
Idirghabháil / cóireáil
Drug: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug)
Other: Placebo Tablet
Céim
Grúpaí Láimhe
| Lámh | Idirghabháil / cóireáil |
|---|---|
| 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) multivitamin |
| 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. | Other: Placebo Tablet |
Critéir Incháilitheachta
| Gnéas Incháilithe le haghaidh Staidéir | All |
| Glacann Oibrithe Deonacha Sláintiúla | Sea |
| Critéir | 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 |
Toradh
Bearta Toraidh Príomhúla
1. 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).]
