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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.

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 are given atorvastatin (a commonly used "statin" drug) to ensure good control of LDL ("bad") cholesterol.

  • Participants also receive 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.

Downloads
 

You can download the following documents in PDF format.

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 happens at the Final Follow-up visit?

The final follow-up visit may take slightly longer than other visits as some additional tests and measurements are done.

Anacetrapib does not have a license currently so it will not be available once the study is completed. At the final visit all participants will be asked to stop taking the REVEAL study tablets. Participants taking the study atorvastatin will need to ask their own doctor to supply statin therapy after the final visit. The study nurses will discuss this with participants during the final visit.

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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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Contraindicated drugs

If you are a REVEAL participant taking one or more of the following drugs, please contact your study nurse or doctor or ring the Freefone service on 0800­ 585 323 (UK) for further advice

1. For lowering cholesterol:

STATINS: if your own doctors wish to change the atorvastatin dose you are receiving in REVEAL or change to a different statin please contact your study clinic first.

FIBRATES:

• Bezafibrate (Bezalip, Bezalip Mono, Bezagen XL, Liparol XL, Zimbacol XL)
• Ciprofibrate (Modalim)
• Fenofibrate (Fenogal, Lipantil, Lipantil Micro, Supralip)
• Gemfibrozil (Lopid)

HIGH DOSE NIACIN (more than 1g per day):

• Nicotinic acid (Niaspan)
• Acipimox (Olbetam)

2. Antibiotics:

• Erythromycin ( Arpamicin, Erymax, Erymin, Erythrocin, Erythroped, Ilosone, Tiloryth)
• Clarithromycin (Klaricid, Crixan, Biaxin, Klabax, Klacid, Claripen, Claridar, Fromilid, Clacid, Clacee, Vikrol, and infex.clariwin)
• Telithromycin (Ketek)
• Daptomycin (Cubicin)

3. Antifungals:

(Excluding creams or eye/ear drops)
• Itraconazole (Sporanox)
• Posaconazole (Noxafil)

If you are taking one of the antibiotics or antifungal medications listed above, you would be able to re-start the study treatment once you have completed the course of tablets.

4. Protease Inhibitors:

• Atazanavir (Reyataz)
• Fosamprenavir (Lexiva)
• Lopinavir (Kaletra)
• Darunavir (Prezista)
• Nelfanavir (Viracept)
• Tionavir (Norvir)
• Saquinavir (Invirase, Fortovase)
• Tipranavir (Aptivus)
• Amprenavir (Agenerase)
• Indinavir (Crixivan)

5. Other:

• Ciclosporin (Neoral, Sandimmun, SangCya)
• Fusidic acid (excluding creams or eye/ear drops)
• Nefazodone (Serzone, Nefadar)

We expect to report the results of the REVEAL trial in 2017 both at a medical conference and in a medical journal. Results will also be posted on this website when they are available. Where possible, participants will be sent a summary of the results.
The Data Analysis Plan was posted on this website on 8th June 2016. A copy is available in the Downloads section.

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