HOPE-3

Heart Outcomes Prevention Evaluation

Ethics approval was gained in late 2007 to take part in this 5 year multinational double blind longitudinal study initiated by an academic research group in Canada headed by Professor Salim Yusef.  The study will evaluate the effects of the most promising components of the polypill, namely combined cholesterol and blood pressure lowering, in approximately 10,0000 study participants who are without vascular disease at baseline.  The study is expected to identify safe and effective CV prevention strategies which could substantially reduce the risk of CVD in large proportions of the adult population worldwide.

The trial will enrol individuals, who in the judgement of their doctor, do not have a clear indication or contraindication to lipid lowering or blood pressure lowering with any of the study drugs. In order to exclude very low risk people, in addition to age, one additional CV risk factor will be required for eligibility in the trial.  The inclusion criteria for the study are women aged ? 65 years and men aged ? 55 years, with one additional CV risk factor (such as current or recent smoker, waist/hip ratio ? 0.90 in men and ? 0.85 in women, family history of premature CHD in first degree relatives (age < 55 years in men or <65 years in women).  Among the exclusion criteria are documented clinical cardiovascular disease or a clear indication for, or contraindication to, statin and/or angiotensin receptor (ARB) or ACE inhibitor and/or thiazide diuretic therapy.  The primary outcome is the composite of CV death, nonfatal myocardial infarction (MI), nonfatal ischemic stroke, resuscitated cardiac arrest and arterial revascularizations.

There will be an initial 4-week run-in phase, where study participants will receive single-blind therapy with rosuvastatin 10 mg and candesartan/HCT 16/12.5 mg daily.  If the medication is well tolerated, the participants will then be randomised to one of the four arms of the study: 1) combined rosuvastatin and candesartan/HCT, 2) candesartan/HCT alone, 3) rosuvastatin alone, 4) placebo.  Follow-up study visits will occur every 6 months for an average of at least 5 years.

HOPE-3 will recruit study participants from about 150 centres in about 9 countries.  The study will be co-ordinated in Australia by the CTC, with worldwide co-ordination being conducted by the Population Health Research Institute, McMaster University and Hamilton Health Sciences.  At present the other Australian site is The George Institute, Sydney.  Study recruitment at the CTC will begin in 2008 via media campaigns, community groups and through associations with general practices.