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HPS3/TIMI55-REVEAL

Randomized EValuation of the Effects of Anacetrapib through Lipid-modification

Welcome to the REVEAL Study website

The REVEAL study is an international clinical trial that aims to find out if treating cholesterol with a new drug called anacetrapib will drive down the risk of heart attacks, deaths from heart disease and other vascular diseases.

The results of the REVEAL main trial were announced at the European Society of Cardiology congress in Barcelona on Tuesday 29th August 2017 and were simultaneously published in the New England Journal of Medicine. You may read or download a copy of the paper from http://www.nejm.org/doi/full/10.1056/NEJMoa1706444. The results are summarised in our press release, which is available in the Download section of this website.

A presentation on the ‘Impact of ADCY9 on Response to Anacetrapib Among 20,000 Participants in the HPS3/TIMI55-REVEAL Trial’ was delivered at the American College of Cardiology Scientific Session on 18 March 2019.

The results of the REVEAL post-trial follow-up were presented at the AHA Scientific Sessions in November 2019. The slides are available in the Download section of this website.

Data sharing requests will be considered after results from the post-trial follow-up phase have been published. See our Data Access Policy for more information.

What does the REVEAL study involve?

  • REVEAL involves over 30,000 men and women who already have 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 or matching placebo (dummy) tablets daily (allocated randomly).

  • The primary aim of the study is to see whether fewer participants given anacetrapib have heart attacks, revascularization procedures or die from coronary heart disease than do those given the placebo tablets.

  • All participants stopped study treatment prior to February 2017 and direct participant follow-up was completed in April 2019. However, in the UK we will continue to collect information on health outcomes via registries and NHS sources. See the Download section for the REVEAL Data Privacy Notice for participants.

Downloads
 

The following downloads are available:

Frequently Asked Questions

What is the purpose of the study?

The study is called the REVEAL trial. It is investigating whether the drug anacetrapib (a CETP inhibitor) in combination with a statin can prevent vascular disease in high risk patients.

REVEAL is the largest study looking into the possible benefits of boosting good cholesterol and further lowering bad cholesterol to prevent heart attacks and strokes in people who have suffered these conditions before, and who are already taking statins. This means that REVEAL is uniquely positioned to answer questions about the contribution of good and bad cholesterol on the risk of serious cardiovascular diseases. 

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Who is running and who is funding the study?

The Clinical Trial Service Unit (CTSU) in the Nuffield Department of Population Health (NDPH) at the University of Oxford is coordinating this study and has overall responsibility for the administration and coordination of the study. There is a Steering Committee to oversee the trial conduct and an independent Data Monitoring Committee perform regular analyses on data collected so far to check that the study tablets aren't causing any illness.

Funding for this study is provided by Merck Sharp & Dohme Corp. to cover the administrative and coordination costs of the trial. The University of Oxford is acting as the sponsor of this study.

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Where is the REVEAL trial registered?

The REVEAL Trial is registered with the following bodies:

• ISRCTN (International Standard Randomised Controlled Trial Number): 48678192
• ClinicalTrials.gov: NCT01252953
• EU Clinical Trials Register: 2010-023467-18
• UKCRN (UK Clinical Research Network): 10598

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What if there is a problem?

If you have any concerns about any possible side-effects of treatment or any complaint about the way you have been dealt with during the study, please call the study team on Freefone 0800­ 585­ 323 (UK).

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The results of the REVEAL main trial were announced at the European Society of Cardiology congress in Barcelona at 07:30 British Summer Time on Tuesday 29th August 2017 and were simultaneously published in the New England Journal of Medicine. You can read or download a copy of the paper from http://www.nejm.org/doi/full/10.1056/NEJMoa1706444. The results are summarised in our press release, available in the Download section.

You can also view a table of adverse events and reactions by MedDRA classification.

24-hour Freefone service: 0800­ 585 323

By post: REVEAL, Clinical Trial Service Unit (CTSU), Richard Doll Building, University of Oxford, Roosevelt Drive, OXFORD, OX3 7LF

By email: reveal@ndph.ox.ac.uk

Clinical Trial Service Unit (CTSU) website: https://www.ctsu.ox.ac.uk

Medical Research Council Population Health Research Unit (MRC PHRU) website: https://www.mrc-phru.ox.ac.uk