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Heart Outcomes Prevention Evaluation–3 (HOPE-3)
This study is currently recruiting participants.
Verified by Population Health Research Institute, June 2007
Sponsored by: 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 we 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 10,000 women 65 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 ten 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: rosuvastatin calcium (10mg)
Drug: candesartan cilexetil (16mg) / hydrochlorothiazide (12.5mg)
Phase IV

MedlinePlus related topics: Cholesterol Heart Attack Heart Diseases
Drug Information available for: Rosuvastatin Rosuvastatin calcium Calcium gluconate Hydrochlorothiazide Candesartan cilexetil CV 11974 Cholest-5-en-3-ol (3beta)-
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: Heart Outcomes Prevention Evaluation–3

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.
  • To evaluate the effects of blood pressure lowering with combined candesartan 16 mg/HCT 12.5 mg daily on major CV events.
  • 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.

Secondary Outcome Measures:
  • Total mortality
  • CV mortality
  • Coronary heart disease events
  • Cerebrovascular disease events
  • Heart failure
  • Revascularization procedures
  • Angina pectoris
  • Progression of renal disease
  • New diagnosis of diabetes

Estimated Enrollment: 10000
Study Start Date: May 2007
Estimated Study Completion Date: May 2013
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women aged > 65 years and men > 55 years
  • 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
  • Severe 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: Jane Shannon hope3@cardio.on.ca
Contact: Andrea Rathe hope3@cardio.on.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

Study ID Numbers: PHRI
Study First Received: May 2, 2007
Last Updated: June 8, 2007
ClinicalTrials.gov Identifier: NCT00468923  
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;   China: Ethics Committee;   China: State Food and Drug Administration;   Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos;   Colombia: Institutional Review Board;   India: Indian Council of Medical Research;   India: Institutional Review Board;   India: Ministry of Health;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   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

Study placed in the following topic categories:
Candesartan cilexetil
Calcium, Dietary
Rosuvastatin
Cerebral Infarction
Candesartan
Stroke
Angiotensin II
Hydrochlorothiazide

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
Antihypertensive Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Membrane Transport Modulators
Angiotensin II Type 1 Receptor Blockers
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009