REVEAL Version 1.0

• Research type

  Research Study

• Full title

  REVEAL: Randomized EValuation of the Effects of Anacetrapib through Lipid-modification. A large-scale, randomized placebo-controlled trial of the clinical effects of anacetrapib among people with established vascular disease

• IRAS ID

  62445

• Contact name

  Martin Landray

• Sponsor organisation

  University of Oxford

• Eudract number

  2010-023467-18

• ISRCTN Number

  48678192

• Research summary

  Previous trials have shown that lowering bad (LDL) cholesterol with statins reduces heart attacks and strokes in a wide range of people at risk of vascular disease. However, among individuals with a previous history of vascular disease or diabetes, the risk of a further vascular event remains high, even after several years of statin treatment. REVEAL will reliably assess the safety and efficacy of a new drug called anacetrapib among people with established vascular disease. Anacetrapib both increases good (HDL) cholesterol and reduces LDL cholesterol. These effects are seen in patients already taking a statin and might produce further reductions in the risk of heart attacks, strokes and bypass surgery beyond the benefits achieved by statin use alone. However, anacetrapib acts by a very different mechanism to statins (it is called a "CETP inhibitor") and a large-scale randomized study, such as REVEAL, is needed to reliably assess the benefits and hazards of this new drug. REVEAL aims to recruit about 30,000 participants worldwide (about 6500 in the UK). Half will be randomly allocated to receive the active treatment (anacetrapib) while the other half will receive a dummy drug ("placebo"). Everyone taking part will take a statin (atorvastatin) along with their allocated study drug for the 4-5 year duration of the study. REVEAL study clinics will be run by trained research staff in NHS and academic institutions. Patients eligible to join the study will be aged 50 or above and have a previous history of vascular disease. Participants will attend the study clinic three times in the first six months and then once every six months. At clinic visits they will be asked to provide blood and urine samples and will be asked about their health. Blood pressure will be measured at each appointment and, at some visits, extra measurements will be taken.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  10/H0605/83

• Date of REC Opinion

  25 Jan 2011

• REC opinion

  Further Information Favourable Opinion