REVEAL: Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification (REVEAL)
|Atherosclerotic Cardiovascular Disease||Drug: anacetrapib Drug: placebo anacetrapib||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official 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|
- Major coronary events (defined as coronary death, myocardial infarction or coronary revascularization procedure) [ Time Frame: Median follow-up of 4 years ]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 Start Date:||June 2011|
|Estimated Study Completion Date:||April 2019|
|Primary Completion Date:||January 31, 2017 (Final data collection date for primary outcome measure)|
tablet, 100mg daily
|Placebo Comparator: placebo anacetrapib||
Drug: placebo anacetrapib
tablet, 1 tablet daily
Sub-study: Does anacetrapib as a CETP inhibitor lead to mobilization of stem cells and enhance myocardial function via neoangiogenesis and tissue regeneration?
Following the main on-treatment part of the study, there will be a further period of at least 2 years during which participants will be followed-up by telephone, off treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252953
|CTSU, University of Oxford|
|Oxford, Oxfordshire, United Kingdom, OX3 7LF|
|Principal Investigator:||Martin Landray||University of Oxford|
|Principal Investigator:||Louise Bowman||University of Oxford|