Status:
COMPLETED
Heart Outcomes Prevention Evaluation-3
Lead Sponsor:
Population Health Research Institute
Conditions:
Cardiovascular Disease
Stroke
Eligibility:
All Genders
55+ years
Phase:
PHASE4
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 sho...
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 med...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
12705 Patients enrolled
Trial Details
Trial ID
NCT00468923
Start Date
May 1 2007
End Date
January 1 2016
Last Update
October 25 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2