HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study
To evaluate whether long term supplementation with folic acid, vitamins B6 and B12 aimed at homocyst(e)ine reduction reduces the rates of major fatal and nonfatal cardiovascular events in patients with established cardiovascular disease and/or diabetes mellitus. HOPE-2 was an investigator initiated trial sponsored by the Canadian Institutes of Health Research. At the time of its publication the HOPE-2 trial was the largest trial of homocysteine lowering B vitamins in CVD prevention. The trial findings of no benefit for B vitamin supplementation influenced guidelines and patterns of practice worldwide.
Randomized, double-blind, placebo control, safety/efficacy, parallel group design.
The primary outcome study endpoint was the composite of CV death, myocardial infarction and stroke. Secondary endpoints: all-cause death, total ischemic events, revascularizations, hospitalization for heart failure, hospitalization for unstable angina, venous thromboembolism, incident cancer and cancer death. All primary and secondary outcomes were adjudicated (except revascularizations).