Heart Outcomes Prevention Evaluation-3 (HOPE-3)

October 23, 2017 updated by: Salim Yusuf's office, Population Health Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

12705

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke.
Time Frame: Biannually
Biannually
The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations
Time Frame: Biannually
Biannually

Secondary Outcome Measures

Outcome Measure
Time Frame
Total mortality
Time Frame: Biannually
Biannually
The components of the co-primary endpoints
Time Frame: Biannually
Biannually

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Investigators

  • Principal Investigator: Salim Yusuf, DPhil FRCPC, McMaster University
  • Principal Investigator: Eva Lonn, MD MSc FRCPC, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 2, 2007

First Submitted That Met QC Criteria

May 2, 2007

First Posted (Estimate)

May 3, 2007

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOPE-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared with participants in the study April/May 2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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