REVEAL: Randomized EValuation of the Effects of Anacetrapib through Lipid-modification
|Funding:||Merck Sharp & Dohme Corp.|
|Collaborators:||Clinical Trials Service Unit (CTSU), University of Oxford|
REVEAL compares anacetrapib 100 mg once daily versus matching placebo in around 30,000 participants with pre-existing atherosclerotic vascular disease who are also receiving effective LDL-lowering therapy using atorvastatin. Follow-up for about 4 years will allow reliable assessments of any beneficial or adverse effects of anacetrapib on mortality and major morbidity. This important international study is coordinated by the Central Coordinating Office at the University of Oxford, with Regional Coordinating Centres responsible for the conduct of the trial in about 400 hospitals worldwide. The study design is streamlined and only essential data is collected directly using bespoke user-friendly computer-based systems.
Primary assessment will involve an intention-to-treat comparison among all randomized participants of the effects of allocation to anacetrapib versus placebo on major coronary events (defined as the occurrence of coronary death, myocardial infarction or coronary revascularization procedure) during the scheduled treatment period. Study website: http://www.ctsu.ox.ac.uk/reveal/index.htm.
The economic analyses of REVEAL will assess the short and long-term cost-effectiveness of anacetrapib intervention in patients with pre-existing atherosclerotic vascular disease already treated with atorvastatin and report the cost per life year gained and per quality-adjusted life year gained for this new intervention.