NCT00468923

Heart Outcomes Prevention Evaluation-3

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12,705 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Cardiovascular Disease
• Stroke

Interventions

Type	Name	Description
DRUG	Candesartan/HCT	Candesartan 16 mg/HCT 12.5 once daily
DRUG	Rosuvastatin	Rosuvastatin 10 mg once daily

Timeline

• Start date: 2007-05-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2007-05-03
• Last updated: 2017-10-25

Locations

1 site across 1 country: Canada