Status:
COMPLETED
VITATOPS: A Study of VITAmins TO Prevent Stroke
Lead Sponsor:
VITATOPS
Collaborating Sponsors:
National Health and Medical Research Council, Australia
National Heart Foundation, Australia
Conditions:
Stroke
Transient Ischemic Attack
Eligibility:
All Genders
Phase:
NA
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, Fol...
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, d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
8164 Patients enrolled
Trial Details
Trial ID
NCT00097669
Start Date
November 1 1998
End Date
June 1 2009
Last Update
September 25 2020
Active Locations (111)
Enter a location and click search to find clinical trials sorted by distance.
1
JFK Hospital / Seton Hall University
New York, New York, United States
2
Abington Memorial Hospital
Abington, Pennsylvania, United States
3
South Carolina VA Hospital
Columbia, South Carolina, United States
4
University of South Carolina
Columbia, South Carolina, United States