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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

Tracking Information
First Submitted Date  ICMJE May 2, 2007
First Posted Date  ICMJE May 3, 2007
Last Update Posted Date October 25, 2017
Study Start Date  ICMJE May 2007
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
  • The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke. [ Time Frame: Biannually ]
  • The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations [ Time Frame: Biannually ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2007)
  • 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.
Change History Complete list of historical versions of study NCT00468923 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
  • Total mortality [ Time Frame: Biannually ]
  • The components of the co-primary endpoints [ Time Frame: Biannually ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2007)
  • 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
Current Other Outcome Measures  ICMJE
 (submitted: February 8, 2017)
  • Renal Dysfunction [ Time Frame: Biannually ]
  • Arterial revascularizations. [ Time Frame: Biannually ]
  • New diagnosis of diabetes. [ Time Frame: Biannually ]
  • All components of the co-primary and secondary outcomes [ Time Frame: Follow-up ]
  • Cognitive function [ Time Frame: Follow-up ]
  • Erectile dysfunction in men [ Time Frame: Biannually ]
  • Myopathy (defined as muscle aches or pains accompanied by CK rise >10ULN). [ Time Frame: Biannually ]
  • Rhabdomyolysis (defined as muscle pain and/or weakness associated with CK rise >10 ULN and evidence of acute renal dysfunction). [ Time Frame: Biannually ]
  • Hospital admissions and the reason for admission. [ Time Frame: Biannually ]
  • Cancer [ Time Frame: Biannually ]
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart Outcomes Prevention Evaluation-3
Official Title  ICMJE Heart Outcomes Prevention Evaluation-3
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.
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 Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Disease
  • Stroke
Intervention  ICMJE
  • Drug: Candesartan/HCT
    Candesartan 16 mg/HCT 12.5 once daily
  • Drug: Rosuvastatin
    Rosuvastatin 10 mg once daily
Study Arms
  • Placebo Comparator: Rosuvastatin
    Rosuvastatin 10 mg vs placebo
    Intervention: Drug: Rosuvastatin
  • Placebo Comparator: Candesartan/HCT
    Candesartan 16 mg/HCT 12.5 mg vs placebo
    Intervention: Drug: Candesartan/HCT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2014)
12705
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2007)
10000
Actual Study Completion Date January 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00468923
Other Study ID Numbers  ICMJE HOPE-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Data will be shared with participants in the study April/May 2016
Responsible Party Salim Yusuf's office, Population Health Research Institute
Study Sponsor  ICMJE Population Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Salim Yusuf, DPhil FRCPC McMaster University
Principal Investigator: Eva Lonn, MD MSc FRCPC McMaster University
PRS Account Population Health Research Institute
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP