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Heart Outcomes Prevention Evaluation-3 (HOPE-3)

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ClinicalTrials.gov Identifier: NCT00468923
Recruitment Status : Completed
First Posted : May 3, 2007
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Salim Yusuf's office, Population Health Research Institute

Study Description
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Brief 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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12705 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Heart Outcomes Prevention Evaluation-3
Study Start Date : May 2007
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke. [ Time Frame: Biannually ]
  2. The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations [ Time Frame: Biannually ]

Secondary Outcome Measures :
  1. Total mortality [ Time Frame: Biannually ]
  2. The components of the co-primary endpoints [ Time Frame: Biannually ]

Other Outcome Measures:
  1. Renal Dysfunction [ Time Frame: Biannually ]
  2. Arterial revascularizations. [ Time Frame: Biannually ]
  3. New diagnosis of diabetes. [ Time Frame: Biannually ]
  4. All components of the co-primary and secondary outcomes [ Time Frame: Follow-up ]
  5. Cognitive function [ Time Frame: Follow-up ]
  6. Erectile dysfunction in men [ Time Frame: Biannually ]
  7. Myopathy (defined as muscle aches or pains accompanied by CK rise >10ULN). [ Time Frame: Biannually ]
  8. Rhabdomyolysis (defined as muscle pain and/or weakness associated with CK rise >10 ULN and evidence of acute renal dysfunction). [ Time Frame: Biannually ]
  9. Hospital admissions and the reason for admission. [ Time Frame: Biannually ]
  10. Cancer [ Time Frame: Biannually ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Salim Yusuf's office, Principal Investigator, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT00468923     History of Changes
Other Study ID Numbers: HOPE-3
First Posted: May 3, 2007    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with participants in the study April/May 2016

Keywords provided by Salim Yusuf's office, Population Health Research Institute:
Primary prevention
Cholesterol lowering
Blood pressure lowering
Cardiovascular disease prevention

Additional relevant MeSH terms:
Cardiovascular Diseases
Rosuvastatin Calcium
Candesartan
Candesartan cilexetil
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists