Status:
Study is completed. Recruitment is now closed. Total recruitment was 8,164 patients. These patients were recruited from 123 centers in 2o countries worldwide. Planned to publish in 2010.
Purpose:
To determine whether lowering plasma homocysteine concentrations by the administration of vitamin supplements (folic acid 2 mg, B6 25 mg, B12 500 μg) will reduce the incidence of vascular sequelae following recent stroke or transient ischemic attacks (TIA).
Interventions:
Vitamins
Attempt to lower homocysteine by vitamin therapy (folate, B6, B12).
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Location(s):
Australia, Austria, Belgium, Brazil, Hong Kong, India, Italy, Malaysia, Moldova, Netherlands, New Zealand, Pakistan, Philippines, Portugal, Republic of Georgia, Serbia & Monte Negro, Singapore, Sri Lanka, United Kingdom, and United States.
Year Started:
1998
Year Finished:
2010
Design:
Multi-center, international, randomized, double-blind, placebo-controlled, secondary-stroke-prevention trial.
Inclusion Criteria
Patients who presented with stroke (ischemic or hemorrhagic) or TIA of the brain or eye within 7 months of onset are eligible for the study.
Exclusion Criteria
Patients who are pregnant or at risk of becoming pregnant, who have a limited life expectancy, who are taking folic acid or B(6) on a physician's advice, taking methotrexate (Folex, Rheumatrex), or who are unwilling to substitute study medications for their own B-vitamin supplements, are excluded from the study.
Patient Involvement:
Patients are randomized in double-blind manner to receive either vitamin supplements [B(12) 500 ug; B(6) 25 mg; folate 2 mg] or a placebo, once daily. They are then to receive follow-up evaluations at 3 months, 6 months, and every 6 months thereafter until the 60-month follow-up period has been completed.
Primary Outcome:
Non-fatal stroke, non-fatal myocardial infarction, or mortality due to vascular causes.
Secondary Outcome:
TIA, revascularisation procedures, dementia, and depression.
Results:
With 8000 patients followed up for a median of 2 years and an annual incidence of the primary outcome of 8% among patients assigned placebo, the study will have at least 80% power to detect a relative reduction of 15% in the incidence of the primary outcome among patients assigned B vitamins (to 6.8%/year), applying a two-tailed level of significance of 5%. VITATOPS aims to recruit and follow-up 8000 patients between 1998 and 2008, and provide a reliable estimate of the safety and effectiveness of folic acid, vitamin B(12), and vitamin B(6) supplementation in reducing recurrent serious vascular events among a wide range of patients with TIA and stroke throughout the world.
Source of Information:
Presented at the 6th World Stroke Conference (Sept 2008).
Presented at the 2008 International Stroke Conference (February 2008).
Presented at the 2007 International Stroke Conference [February 2007].
Presented at the 2006 International Stroke Conference [February 2006].
30th International Stroke Conference [February 2005]. Cerebrovasc Dis 2002; 13(2):120-6.
Presented at 13th European Stroke Conference [May 2004].
Presented at 2010 ESC [May 2010).
Stroke 2004 35: e359 - e36.
Stroke. 2000;31:2536.
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