Heart Outcomes Prevention Trial (HOPE)-3 - HOPE-3

• Conditions: Healthy individuals at average risk, without a clear indication or contraindication to lipid lowering or blood pressure lowering with any of the study drugs. Women aged >65 and men aged >55, with one additonal CV risk factor (for details: see Protocol), are eligible in the absence of documented clinically manifest atherothrombotic CVD, or other major illness(es) expected to interfere with study paricipation.

• Registration Number: EUCTR2007-001493-91-NL
• Lead Sponsor: Population Health Research Institute (PHRI), McMaster University/Hamilton Health Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-26
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

-Women aged ³ 65 years and men ³ 55 years
-One additional CV risk factor
Suggested CV risk factors for trial eligibility:
oWaist/hip ratio = 0.90 in men and = 0.85 in women
oHistory of current or recent smoking (regular tobacco use within 5 years)
oLow HDL cholesterol (for example, HDL cholesterol < 1.0 mmol/L [40 mg/dl]
in men and <1.3 mmol/L [50 mg/dl] in women)
oDysglycemia (impaired fasting glucose [IFG], impaired glucose tolerance
[IGT] or uncomplicated diabetes treated by diet only or at most one oral
hypoglycaemic drug)
oRenal dysfunction
-Microalbuminuria
-estimated GFR <60 ml/min or creatinine > 124 µmol/L (1.4 mg/dL)
oFamily history of premature CHD in first degree relatives (age < 55 years
in men or <65 years in women)
-Provision of informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Documented clinically manifest atherothrombotic CVD
-Clear indication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic
therapy, as determined by the subject’s own local physician
-Clear contraindication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic
therapy, as determined by the subject’s own local physician
-Symptomatic hypotension
-Chronic liver disease (i.e. cirrhosis or persistent hepatitis) or abnormal liver function,
i.e. ALT or AST > 3 x upper limit of normal [ULN]
-Inflammatory muscle disease (such as dermatomyositis or polymyositis) or creatine
kinase (CK) > 3 x ULN
-Severe renal impairment (calculated creatinine clearance [CrCl] <30 ml/min/1.73 m2
or serum creatinine > 264µmol/L (3.0 mg/dl)
-Concurrent treatment with cyclosporine or a condition likely to result in organ
transplantation and the need for cyclosporine
-Concurrent treatment with a statin or a fibrate (subjects on cholesterol-lowering
diets or drugs other than statins or fibrates can still be included).
-Concurrent treatment with an angiotensin receptor blocker, ACE inhibitor, 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 clinical trial of medicinal product
• Study Design: Not specified