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Heart Outcomes Prevention Evaluation-3 (HOPE-3)
This study is currently recruiting participants.
Verified by Population Health Research Institute, October 2009
First Received: May 2, 2007   Last Updated: December 24, 2009   History of Changes
Sponsor: Population Health Research Institute
Information provided by: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT00468923
  Purpose

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. The trial will enroll 11,000 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 will be randomized to receive either the real study medications or placebo (dummy pills) and will be monitored for an average of 5 years. The rates of heart attacks, strokes, deaths and other cardiovascular complications will be compared between subjects receiving the real drugs and those on placebo. The study will include people from at least 20 countries, will be monitored an international group of scientists and physicians and will be 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.


Condition Intervention Phase
Cardiovascular Disease
Stroke
Drug: Candesartan cilexetil/hydrochlorothiazide
Drug: Rosuvastatin
Phase IV

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: Heart Outcomes Prevention Evaluation-3

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • 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: Bimonthly ] [ Designated as safety issue: No ]
  • To evaluate the effects of blood pressure lowering with combined candesartan 16 mg/HCT 12.5 mg daily on major CV events. [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
  • 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: Bimonthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total mortality [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
  • CV mortality [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
  • Coronary heart disease events [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
  • Cerebrovascular disease events [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
  • Heart failure [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
  • Revascularization procedures [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
  • Angina pectoris [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
  • Progression of renal disease [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
  • New diagnosis of diabetes [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]

Estimated Enrollment: 11000
Study Start Date: May 2007
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rosuvastatin: Placebo Comparator
Rosuvastatin 10 mg vs placebo
Drug: Rosuvastatin
Rosuvastatin 10 mg once daily
Candesartan/HCT: Placebo Comparator
Candesartan 16 mg/HCT 12.5 mg vs placebo
Drug: Candesartan cilexetil/hydrochlorothiazide
Candesartan cilexetil 16 mg/hydrochlorothiazide 12.5 once daily

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468923

Contacts
Contact: Andrea Rathe hope3@phri.ca
Contact: Jackie Bosch hope3@phri.ca

Locations
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Population Health Research Institute
Investigators
Principal Investigator: Salim Yusuf, DPhil FRCPC McMaster University
Principal Investigator: Eva Lonn, MD MSc FRCPC McMaster University
  More Information

No publications provided

Responsible Party: Population Health Research Institute ( Dr. Salim Yusuf )
Study ID Numbers: PHRI
Study First Received: May 2, 2007
Last Updated: December 24, 2009
ClinicalTrials.gov Identifier: NCT00468923     History of Changes
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Argentina: Human Research Bioethics Committee;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Australia: Human Research Ethics Committee;   Brazil: National Committee of Ethics in Research;   Brazil: National Health Surveillance Agency;   Canada: Health Canada;   Canada: Ethics Review Committee;   Chile: Instituto de Salud Publica de Chile;   China: Ethics Committee;   China: State Food and Drug Administration;   Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos;   Colombia: Institutional Review Board;   Czech Republic: Ethics Committee;   Czech Republic: State Institute for Drug Control;   Hungary: National Institute of Pharmacy;   India: Indian Council of Medical Research;   India: Institutional Review Board;   India: Ministry of Health;   Malaysia: Office of Deputy Director-General of Health;   Malaysia: Ministry of Health;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Philippines: Department of Health Bureau Food and Drugs;   Slovakia: SUKL;   South Africa: Medicines Control Council;   Sweden: Medical Products Agency;   Sweden: Regional Ethical Review Board

Keywords provided by Population Health Research Institute:
Primary prevention
Cholesterol lowering
Blood pressure lowering
Cardiovascular disease prevention

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Enzyme Inhibitors
Anticholesteremic Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Membrane Transport Modulators
Rosuvastatin
Natriuretic Agents
Therapeutic Uses
Candesartan
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 04, 2010