REVEAL : Randomised Evaluation of the Effects of Anacetrapib through Lipid-modification

REVEAL was a randomised trial investigating the effects of adding anacetrapib (a potent CETP inhibitor) to effective LDL-lowering treatment with atorvastatin. Between 2011 and 2013 REVEAL recruited over 30,000 men and women who already had some form of circulatory disease. Participants were recruited from over 430 hospitals and clinics in the UK, North America, China, Germany, Italy and Scandinavia. All study participants were given atorvastatin (a commonly used "statin" drug) to ensure good control of LDL ('bad') cholesterol. Participants also received either anacetrapib 100mg or matching placebo (dummy) tablets daily (allocated randomly).

The primary aim of the study was to see whether fewer participants given anacetrapib had heart attacks, revascularization procedures or died from coronary heart disease than those given the placebo tablets. Secondary aims included assessment of the safety of anacetrapib, as well as the effects on a number of other outcomes.

The trial was coordinated at CTSU, with academic collaborators leading regional coordinating centres in Europe, North America and China. The University of Oxford is the trial Sponsor. Financial support was provided by Merck Sharp & Dohme. See Oxford Population Health's Independence of Research strategy.

Results were published in 2017 and showed that anacetrapib lowers the risk of heart attack and related cardiovascular complications among high risk patients who are receiving intensive statin treatment. The treatment was well tolerated and there were no major safety concerns.

The REVEAL post-trial follow-up results were published in December 2021. They showed that the beneficial effects of anacetrapib on major coronary events increased with longer follow-up, with no adverse effects emerging for non-vascular mortality or morbidity. These findings illustrate the importance of sufficiently long treatment and follow-up duration in randomised trials of lipid-modifying agents to assess their full benefits and harms.

Long-term follow-up information

All participants stopped study treatment prior to February 2017 and direct participant follow-up was completed in April 2019. However, in the UK we continue to collect information on health outcomes via central data registries and NHS sources until 2034. See REVEAL Long term Study Information for Participants (PDF) document for further details. 

patient and public involvement and engagement (PPIE)

If you were a participant in the REVEAL trial and would like to join the Oxford Population Health PPIE group we would love to hear from you. PPIE is very important for learning about the lived experience of our trial participants and providing feedback about new and ongoing research projects. The Oxford Population Health website gives more information on what this group does and how to get in touch.

Documents 

Poster: Study Treatment Adherence Management Using an e-module in a Large Streamlined Randomised Controlled Trial [PDF]

Data Privacy Notice v2.1.

Main Trial Protocol v2.0 [PDF]

Main Trial Data Analysis Plan v1.1 [PDF]

Main Trial Results slides – ESC 2017 [PDF]

REVEAL Patient Information Leaflet v2.0 [PDF]

Long-Term Study Information for Participants v1.0 [PDF]

Post-trial Follow-up Protocol v3.0 [PDF]

Post-trial Follow-up Data Analysis Plan v1.0 [PDF]

Post-trial Follow-up Results slides – AHA 2019 [PDF]