Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Heart Outcomes Prevention Evaluation-3 (HOPE-3)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Salim Yusuf's office, Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT00468923
First received: May 2, 2007
Last updated: February 13, 2014
Last verified: February 2014
  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.


Condition Intervention Phase
Cardiovascular Disease
Stroke
Drug: Candesartan/HCT
Drug: Rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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: Biannually ] [ 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: Biannually ] [ 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: Biannually ] [ Designated as safety issue: No ]

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

Enrollment: 12705
Study Start Date: May 2007
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Rosuvastatin
Rosuvastatin 10 mg vs placebo
Drug: Rosuvastatin
Rosuvastatin 10 mg once daily
Placebo Comparator: Candesartan/HCT
Candesartan 16 mg/HCT 12.5 mg vs placebo
Drug: Candesartan/HCT
Candesartan 16 mg/HCT 12.5 once daily

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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468923

Locations
Canada, Ontario
Hamilton General Hospital
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: Salim Yusuf's office, Principal Investigator, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT00468923     History of Changes
Other Study ID Numbers: PHRI
Study First Received: May 2, 2007
Last Updated: February 13, 2014
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 Pública de Chile
China: Ethics Committee
China: 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:
Cardiovascular Diseases
Candesartan
Candesartan cilexetil
Rosuvastatin
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anticholesteremic Agents
Antihypertensive Agents
Antimetabolites
Cardiovascular Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014