Overview

This trial is active, not recruiting.

Conditions cardiovascular disease, stroke
Treatments candesartan/hct, rosuvastatin
Phase phase 4
Sponsor Population Health Research Institute
Start date May 2007
End date October 2015
Trial size 12705 participants
Trial identifier NCT00468923, HOPE-3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
Rosuvastatin 10 mg vs placebo
rosuvastatin
Rosuvastatin 10 mg once daily
(Placebo Comparator)
Candesartan 16 mg/HCT 12.5 mg vs placebo
candesartan/hct
Candesartan 16 mg/HCT 12.5 once daily

Primary Outcomes

Measure
To evaluate the effects of lipid modification (LDL cholesterol lowering and HDL cholesterol raising) with rosuvastatin 10 mg daily on major CV events.
time frame: Biannually
To evaluate the effects of blood pressure lowering with combined candesartan 16 mg/HCT 12.5 mg daily on major CV events.
time frame: Biannually
To evaluate the impact of combined lipid modification with rosuvastatin 10 mg/day and blood pressure lowering with candesartan 16 mg/HCT 12.5 mg daily on major CV events.
time frame: Biannually

Secondary Outcomes

Measure
Total mortality
time frame: Biannually
CV mortality
time frame: Biannually
Coronary heart disease events
time frame: Biannually
Cerebrovascular disease events
time frame: Biannually
Heart failure
time frame: Biannually
Revascularization procedures
time frame: Biannually
Angina pectoris
time frame: Biannually
Progression of renal disease
time frame: Biannually
New diagnosis of diabetes
time frame: Biannually

Eligibility Criteria

Male or female participants at least 55 years old.

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

Additional Information

Official title Heart Outcomes Prevention Evaluation-3
Principal investigator Salim Yusuf, DPhil FRCPC
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Population Health Research Institute.