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Research

Photo for HOPE - 2

HOPE - 2

Official Title

HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study

Status

Completed

Overview

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.

Study Design

Randomized, double-blind, placebo control, safety/efficacy, parallel group design.

Primary Endpoint

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).

Number of Patients

5542

Number of Sites

145

Number of Countries

13

Study Period

1999–2003

Principal Investigator

Eva Lonn

Program Manager

Not Applicable

Research Coordinator

Jackie Bosch

Key Publications

  • Lonn E, Yusuf S, Arnold MJ, Sheridan P, Pogue J, Micks M, McQueen MJ, Probstfield J, Fodor G, Held C, Genest J Jr; Heart Outcomes Prevention Evaluation (HOPE) 2 Investigators. Homocysteine lowering with folic acid and B vitamins in vascular disease. N Engl J Med. 2006;354:1567-77. Epub 2006 Mar 12.
  • Saposnik G, Ray JG, Sheridan P, McQueen M, Lonn E; the HOPE 2 Investigators. Homocysteine-Lowering Therapy and Stroke Risk, Severity, and Disability. Additional Findings From the HOPE 2 Trial. Stroke. 2009 Feb 19. [Epub ahead of print]
  • Ray JG, Kearon C, Yi Q, Sheridan P, Lonn E; Heart Outcomes Prevention Evaluation 2 (HOPE-2) Investigators. Homocysteine-lowering therapy and risk for venous thromboembolism: a randomized trial. Ann Intern Med. 2007;146:761-7. Epub 2007 Apr 30.