Landmark Research Studies
completed

The objective of HOPE was to evaluate the use of the ACE inhibitor, ramipril, and of vitamin E in high-risk patients with chronic stable vascular disease and/or diabetes and additional risk factor(s). The trial showed clear benefit for ramipril and a neutral effect for vitamin E. HOPE led to regulatory approvals for a new indication for the study drug in 40 countries, with major impact on guidelines and patterns of practice worldwide.

The HOPE Extension trial consisted of passive follow-up for ramipril arm of the trial and continued blinded study drug administration and follow-up for the vitamin E of the trial for additional 2.6 years. The extension showed maintained benefit for ramipril and neutral effect for vitamin E.

HOPE included a large number of substudies and additional analyses (carotid IMT, LV function, economic substudy, biomarkers, renal outcomes, heart failure, effects in people with diabetes, women, the elderly) and more than 60 publications – one of which, in the The New England Journal of Medicine, was the most highest cited publication in clinical medicine in year 2001.

The primary study outcome was the composite of CV death, myocardial infarction and stroke. Secondary outcomes were all-cause death, revascularizations, hospitalization for heart failure, hospitalization for unstable angina and complications related to diabetes. All primary and secondary outcomes were adjudicated (except revascularizations.)

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Study Type

Interventional - Drug

Study Design

Randomized double-blind controlled trial with a two-by-two factorial design

NO. of Countries

19

NO. of Sites

267

NO. of Participants

9541

Study Period

1993-1999

Sponsor

PHRI

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