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Sponsors and Collaborators: |
Hamilton Health Sciences Canadian Institutes of Health Research (CIHR) Population Health Research Institute |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00217178 |
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 progression, as evaluated by quantitative B-mode carotid ultrasound (US).
Condition | Intervention | Phase |
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Atherosclerosis Cardiovascular Disease |
Drug: Vitamins: Folic acid, B6, B12 |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Homocysteine Lowering and Atherosclerosis Reduction Trial (HART) |
Estimated Enrollment: | 900 |
Study Start Date: | January 2000 |
Estimated Study Completion Date: | October 2005 |
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 events. The study is designed to enrol 900 study participants randomized to homocysteine lowering therapies or placebo. Follow-up will estimate over 5 years. Study participants will undergo yearly carotid B-Mode ultrasound examinations.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: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 Criteria:1. 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.
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Canada, Ontario | |
Hamilton Health Sciences Corp. | |
Hamilton, Ontario, Canada, L8L 2X2 |
Principal Investigator: | Eva M Lonn, MD MSc FRCPC FACC | McMaster University |
Study ID Numbers: | HART, CIHR Grant # MCT 44159, CIHR, MCT 44159 |
Study First Received: | September 16, 2005 |
Last Updated: | September 16, 2005 |
ClinicalTrials.gov Identifier: | NCT00217178 |
Health Authority: | Canada: Health Canada |
Atherosclerosis CV Risk Factors Homocysteine CV disease Cardiovascular disease |
Folic Acid Arterial Occlusive Diseases Atherosclerosis Vascular Diseases Arteriosclerosis |
Cardiovascular Diseases |