Status:
UNKNOWN
Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Population Health Research Institute
Conditions:
Atherosclerosis
Cardiovascular Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief Summary
Study Objective: 1\. To evaluate whether combined therapy with folic acid 2.5 mg/day, vitamin B6 50 mg/day and vitamin B12 1000 micrograms/day vs placebo reduces the rate of atherosclerosis progressi...
Detailed Description
The HART study is designed as a substudy of the Heart Outcomes Prevention Evaluation-2 (HOPE-2)trial which evaluates the effect of combined therapy ? folic acid and vitamin B6 and B12 on clinical even...
Eligibility Criteria
Inclusion
- Women and Men aged ≥ 55 years at high risk for CV events with: (a) Documented (CAD): i) History of prior MI; ii) stable or unstable angina with documented multivessel CAD or strongly positive stress test; iii) Multivessel CAD and PTCA ≥ 6 months prior to randomization; iv) multivessel CABG ≥ 4 years prior to randomization; v) Multivessel CAD on angiography; (b) Documented peripheral vascular disease (PVD): i) Previous limp bypass surgery and/or previous peripheral percutaneous transluminal angioplasty and/or previous limp or foot amputation due to PVD.ii) History of intermittent claudication with ankle/arm blood pressure ratio of ≤ 0.80 or with significant arterial stenosis on angiography; (c) Documented cerebrovascular disease: i) History of previous ischemic stroke; and (d) Diabetes mellitus with ≥ 1 additional major CV risk factor(s). (2) Provision of informed consent.(3) Adequate baseline carotid US examination.
Exclusion
- Current use of folic acid supplements \> 200 mg/day. 2. Known previous adverse reactions to folic acid, Vitamin B6 or B12. 3. Planned cardiac, peripheral or cerebrovascular.
- \-
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00217178
Start Date
January 1 2000
End Date
October 1 2005
Last Update
September 22 2005
Active Locations (1)
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1
Hamilton Health Sciences Corp.
Hamilton, Ontario, Canada, L8L 2X2