Heart Outcomes Prevention Evaluation-3

Stroke Clinical Trial

— HOPE-3  

Official title:

Heart Outcomes Prevention Evaluation-3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468923
• Other study ID #: HOPE-3
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2007
• Last updated: October 23, 2017
• Start date: May 2007
• Est. completion date: January 2016

Study information

• Verified date: October 2017
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12705
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Stroke

Intervention

Drug:
• Candesartan/HCT
Candesartan 16 mg/HCT 12.5 once daily
• Rosuvastatin
Rosuvastatin 10 mg once daily

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Lonn EM, Bosch J, López-Jaramillo P, Zhu J, Liu L, Pais P, Diaz R, Xavier D, Sliwa K, Dans A, Avezum A, Piegas LS, Keltai K, Keltai M, Chazova I, Peters RJ, Held C, Yusoff K, Lewis BS, Jansky P, Parkhomenko A, Khunti K, Toff WD, Reid CM, Varigos J, Leiter — View Citation

Yusuf S, Bosch J, Dagenais G, Zhu J, Xavier D, Liu L, Pais P, López-Jaramillo P, Leiter LA, Dans A, Avezum A, Piegas LS, Parkhomenko A, Keltai K, Keltai M, Sliwa K, Peters RJ, Held C, Chazova I, Yusoff K, Lewis BS, Jansky P, Khunti K, Toff WD, Reid CM, Va — View Citation

Yusuf S, Lonn E, Pais P, Bosch J, López-Jaramillo P, Zhu J, Xavier D, Avezum A, Leiter LA, Piegas LS, Parkhomenko A, Keltai M, Keltai K, Sliwa K, Chazova I, Peters RJ, Held C, Yusoff K, Lewis BS, Jansky P, Khunti K, Toff WD, Reid CM, Varigos J, Accini JL, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Renal Dysfunction		Biannually
Other	Arterial revascularizations.		Biannually
Other	New diagnosis of diabetes.		Biannually
Other	All components of the co-primary and secondary outcomes		Follow-up
Other	Cognitive function		Follow-up
Other	Erectile dysfunction in men		Biannually
Other	Myopathy (defined as muscle aches or pains accompanied by CK rise >10ULN).		Biannually
Other	Rhabdomyolysis (defined as muscle pain and/or weakness associated with CK rise >10 ULN and evidence of acute renal dysfunction).		Biannually
Other	Hospital admissions and the reason for admission.		Biannually
Other	Cancer		Biannually
Primary	The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke.		Biannually
Primary	The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations		Biannually
Secondary	Total mortality		Biannually
Secondary	The components of the co-primary endpoints		Biannually