THE HOPE (HEART OUTCOMES PREVENTION EVALUATION) STUDY - THE DESIGN OFA LARGE, SIMPLE RANDOMIZED TRIAL OF AN ANGIOTENSIN-CONVERTING ENZYME-INHIBITOR (RAMIPRIL) AND VITAMIN-E IN PATIENTS AT HIGH-RISK OF CARDIOVASCULAR EVENTS
F. Mindlen et al., THE HOPE (HEART OUTCOMES PREVENTION EVALUATION) STUDY - THE DESIGN OFA LARGE, SIMPLE RANDOMIZED TRIAL OF AN ANGIOTENSIN-CONVERTING ENZYME-INHIBITOR (RAMIPRIL) AND VITAMIN-E IN PATIENTS AT HIGH-RISK OF CARDIOVASCULAR EVENTS, Canadian journal of cardiology, 12(2), 1996, pp. 127-137
OBJECTIVE: To describe the design of the HOPE (Heart Outcomes Preventi
on Evaluation) Study. DESIGN: Description of the key design features o
f HOPE, a large, simple randomized trial of two widely applicable trea
tments - ramipril, an angiotensin-converting enzyme inhibitor; and vit
amin E, a naturally occurring antioxidant vitamin - in the prevention
of myocardial infarction, stroke or cardiovascular death. SETTING: Two
-hundred and sixty-seven hospitals, physician offices and clinics in C
anada, the United States, Mexico, Europe and South America. PATIENTS:
Over 9000 women and men aged 55 years and above at high risk for cardi
ovascular events such as myocardial infarction and stroke were recruit
ed over 18 months. INTERVENTIONS: A 2x2 factorial design with ramipril
and vitamin E with follow-up for up to four years. CONCLUSIONS: HOPE
will be one of the largest trials of two new interventions to prevent
myocardial infarction, stroke or cardiovascular death in high risk pat
ients. The results of HOPE will have direct public health impact and a
re likely to be readily incorporated into clinical practice. Key desig
n features of HOPE are inclusion of individuals at high risk of cardio
vascular disease, inclusion of a substantial proportion of patients wi
th diabetes (36%) and women (27%), and detailed substudies to provide
data on mechanisms of benefit.