Heart Outcomes Prevention Evaluation-3 (HOPE-3)
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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 |
- 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: Bimonthly ] [ 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: Bimonthly ] [ 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: Bimonthly ] [ Designated as safety issue: No ]
- Total mortality [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
- CV mortality [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
- Coronary heart disease events [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
- Cerebrovascular disease events [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
- Heart failure [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
- Revascularization procedures [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
- Angina pectoris [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
- Progression of renal disease [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
- New diagnosis of diabetes [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 11000 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 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 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 |
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| Canada, Ontario | |
| Hamilton General Hospital | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| 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: | May 14, 2013 |
| 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 Publica 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 Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Candesartan Candesartan cilexetil Rosuvastatin Antihypertensive Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Enzyme Inhibitors Lipid Regulating Agents |
ClinicalTrials.gov processed this record on June 17, 2013