Heart Outcomes Prevention Evaluation-3

Phase 4

Completed

• Conditions: Cardiovascular Disease; Stroke
• Interventions: Drug: Rosuvastatin; Drug: Candesartan/HCT

• Registration Number: NCT00468923
• Lead Sponsor: Population Health Research Institute

Brief 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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-02
• Study First Submitted QC: 2007-05-02
• Study First Posted: 2007-05-03
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12705

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin	Rosuvastatin 10 mg vs placebo
Candesartan/HCT	Candesartan/HCT	Candesartan 16 mg/HCT 12.5 mg vs placebo

Primary Outcome Measures

Name	Time	Method
The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke.	Biannually
The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations	Biannually

Secondary Outcome Measures

Name	Time	Method
The components of the co-primary endpoints	Biannually
Total mortality	Biannually

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada