Heart Outcomes Prevention Evaluation-3 (HOPE-3)

Population Health Research Institute (PHRI)

Status and phase

Completed

Phase 4

Conditions

Stroke

Cardiovascular Disease

Treatments

Drug: Rosuvastatin

Drug: Candesartan/HCT

Study type

Interventional

Funder types

Other

Identifiers

NCT00468923

HOPE-3

Details and patient eligibility

About

Heart disease and stroke are major causes of death and disability worldwide and are largely preventable. Cholesterol and blood pressure are major cardiovascular risk factors. Previous studies have shown that certain drugs can effectively and safely lower cholesterol and blood pressure and prevent heart attacks and strokes. Such studies have been conducted primarily in people who had already sustained a heart attack or a stroke, or in people with high cholesterol and blood pressure levels. However, most heart attacks and strokes occur in people with average ("normal") cholesterol and blood pressure. Therefore, in the HOPE-3 trial the investigators will evaluate whether a cholesterol lowering drug, rosuvastatin, and a combination blood pressure lowering pill, candesartan/hydrochlorothiazide, used alone or together can reduce the risk of heart attacks, stroke and their sequelae in people without known heart disease and at average risk.

Full description

The trial has randomized 12,705 women 60 years or older and men 55 years or older without known heart disease or prior stroke and without a clear indication or contraindication to any of the study medications. Eligible and consenting individuals were randomized to receive either active study medications or placebo (dummy pills) and will be monitored for an average of 5.7 years. The rates of heart attacks, strokes, deaths and other cardiovascular events will be compared between subjects receiving the active drugs and those on placebo. The study included people from 21 countries, which were monitored by an international group of scientists and physicians. The study was coordinated by the Population Health Research Institute at McMaster University. The study is expected to demonstrate that combined lipid lowering and blood pressure lowering will substantially lower the risk for cardiovascular diseases and may substantially change our approach to cardiovascular prevention.

Enrollment

12,705 patients

Sex

All

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Women aged > 60 years and men > 55 years
At least one additional CV risk factor including:
Waist/hip ratio ≥ 0.90 in men and ≥ 0.85 in women;
History of current or recent smoking (regular tobacco use within 5 years)
Low HDL cholesterol
Dysglycemia
Renal dysfunction
Family history of premature CHD in first degree relatives

Exclusion criteria

Documented clinically manifest atherothrombotic CVD
Clear indication or contraindication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic therapy
Symptomatic hypotension
Chronic liver disease
Inflammatory muscle disease
Renal impairment
Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine
Concurrent treatment with a statin, fibrate, angiotensin receptor blocker, ACE inhibitor, or a thiazide diuretic
Other serious medical illness likely to interfere with study participation or with the ability to complete the trial
Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures
Concurrent use of an experimental pharmacological agent