|
Welcome
|
|
12 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ ...Back to search results ] | [ Print-friendly version ] |
| Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial |
| ISRCTN | ISRCTN14780645 |
| ClinicalTrials.gov identifier | NCT00468923 |
| Public title | Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial |
| Scientific title | Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial: a large simple randomised trial of combined cholesterol modification and blood pressure lowering in middle aged people at average risk |
| Acronym | HOPE-3 |
| Serial number at source | IR2-91038 |
| Study hypothesis |
In individuals at moderate risk and without known atherothrombotic cardiovascular disease (CVD):
1. To evaluate the effects of lipid modification (low density lipoprotein [LDL] cholesterol lowering and high density lipoprotein [HDL] cholesterol raising) with rosuvastatin 10 mg daily on major cardiovascular (CV) events 2. To evaluate the effects of blood pressure lowering with combined candesartan 16 mg/hydrochlorothiazide (HCT) 12.5 mg daily on major CV events 3. 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 |
| Lay summary | Not provided at time of registration |
| Ethics approval | Research Ethics Board of McMaster University gave approval on the 16th April 2007 (ref: 06-434) |
| Study design | Interventional randomised controlled trial |
| Countries of recruitment | Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Hungary, India, Korea, South, Malaysia, Netherlands, Philippines, Russian Federation, Slovakia, South Africa, Sweden, Ukraine |
| Disease/condition/study domain | Cardiovascular disease/stroke |
| Participants - inclusion criteria |
1. Women aged greater than or equal to 60 years with at least two additional risk factors and, women aged greater than or equal to 65 years and men greater than or equal to 55 years with at least one additional risk factor
2. Suggested CV risk factors for trial eligibility: 2.1. Waist/hip ratio greater than 0.90 in men and greater than 0.85 in women 2.2. History of current or recent smoking (regular tobacco use within 5 years) 2.3. Low HDL cholesterol (for example, HDL cholesterol less than 1.0 mmol/L [40 mg/dl] in men and less than 1.3 mmol/L [50 mg/dl] in women) 2.4. Dysglycaemia (impaired fasting glucose [IFG], impaired glucose tolerance [IGT] or uncomplicated diabetes treated by diet only) 2.5. Renal dysfunction: 2.5.1. Microalbuminuria 2.5.2. Estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m^2 or serum creatinine greater than 124 µmol/L (1.4 mg/dL) (unless participant has proteinuria or blood pressure above 130/80 mmHg) 2.6. Family history of premature coronary heart disease (CHD) in first degree relatives (age less than 55 years in men or less than 65 years in women) 3. Provision of informed consent |
| Participants - exclusion criteria |
1. Documented clinically manifest atherothrombotic CVD
2. Clear indication for statin and/or angiotensin-receptor blocker (ARB) or angiotensin converting enzyme (ACE) inhibitor and/or thiazide diuretic therapy, as determined by the subject's own local physician 3. Clear contraindication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic therapy, as determined by the subject's own local physician 4. Symptomatic hypotension 5. Chronic liver disease (i.e. cirrhosis or persistent hepatitis) or abnormal liver function, i.e. alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 x upper limit of normal (ULN) 6. Inflammatory muscle disease (such as dermatomyositis or polymyositis) or creatine kinase (CK) greater than 3 x ULN 7. Moderate renal dysfunction (serum creatinine greater than 180 µmol/L [2.0 mg/dl] or eGFR less than 45 ml/min/1.73 m^2) 8. Mild renal dysfunction (eGFR less than 60 ml/min/1.73 m^2) and proteinuria or blood pressure above 130/80 mmHg 9. Concurrent treatment with cyclosporin or a condition likely to result in organ transplantation and the need for cyclosporin 10. Concurrent treatment with a statin or a fibrate (subjects on cholesterol-lowering diets or drugs other than statins or fibrates can still be included) 11. Concurrent treatment with an angiotensin receptor blocker, ACE inhibitor, or a thiazide diuretic 12. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial 13. 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 14. Concurrent use of an experimental pharmacological agent |
| Anticipated start date | 01/05/2007 |
| Anticipated end date | 31/05/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 11000 |
| Interventions |
Experimental group:
Rosuvastatin 10 mg, once a day Candesartan 16 mg/hydrochlorothiazide (HCT) 12.5 mg, once a day Control group: Matching placebo 10 mg, once a day Matching placebo 16 mg/HCT 12.5 mg, once a day An average of at least 5 years of follow-up for both study arms. Contact for public queries: HOPE-3 Project Office 237 Barton St. E. Hamilton, Ontario L8L 2X2 Canada Tel: +1 905 527 4322 ext. 44529 Fax: +1 905 527 5380 Email: hope3@phri.ca |
| Primary outcome measure(s) | The composite of CV death, non-fatal myocardial infarction (MI) and non-fatal stroke, measured at 6 weeks, 6 months and then every 6 months until study end. |
| Secondary outcome measure(s) |
1. The composite of CV death, non-fatal MI, non-fatal stroke, resuscitated cardiac arrest, coronary revascularisation with objective evidence of ischaemia and heart failure measured at 6 weeks, 6 months, and then every 6 months until study end
2. Total mortality measured at 6 weeks, 6 months, and then every 6 months until study end |
| Sources of funding |
1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: IR2-91038)
2. AstraZeneca (Canada) |
| Trial website | http://rome.cardio.on.ca/hope3 |
| Publications | |
| Contact name | Dr Salim Yusuf |
| Address |
Population Health Research Institute
McMaster Clinic 237 Barton Street East |
| City/town | Hamilton, Ontario |
| Zip/Postcode | L8L 2X2 |
| Country | Canada |
| Tel | +1 905 527 7327 |
| Fax | +1 905 521 1166 |
| hope3@phri.ca | |
| Sponsor | Hamilton Health Sciences Corporation (Canada) |
| Address | 237 Barton Street East |
| City/town | Hamilton, Ontario |
| Zip/Postcode | L8L 2X2 |
| Country | Canada |
| Sponsor website: | http://www.hamiltonhealthsciences.ca/ |
| Date applied | 07/10/2008 |
| Last edited | 16/08/2011 |
| Date ISRCTN assigned | 12/11/2008 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|