Heart Outcomes Prevention Evaluation-3

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Candesartan; Candesartan cilexetil; Rosuvastatin Calcium

Criteria

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