The Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification (REVEAL) trial aims to determine whether lipid modification with anacetrapib 100mg daily reduces the risk of coronary death, myocardial infarction (MI) or coronary revascularization (collectively known as major coronary events) in patients with circulatory problems who have their Low-density Lipoprotein (LDL) cholesterol level treated with a statin.
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 was a further period of at least 2 years during which participants were followed-up by telephone, off treatment. All participants stopped study treatment prior to February 2017 (results for the main-trial have been reported) and direct participant follow-up was completed in April 2019. In the UK we will continue to collect information on health outcomes via central data registries and NHS sources for many years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
30,449
tablet, 100mg daily
tablet, 1 tablet daily
CTSU, University of Oxford
Oxford, Oxfordshire, United Kingdom
Number of Participants With Major Coronary Event
Primary assessment involves 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. Data reported is for the first major coronary event.
Time frame: Randomized treatment phase during median follow-up period of 4.1years
Number of Participants With Major Atherosclerotic Event
Major atherosclerotic events (defined as coronary death, myocardial infarction or presumed ischaemic stroke; the key secondary outcome). Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period.
Time frame: Randomized treatment phase during median follow-up period of 4.1years
Number of Participants With Presumed Ischaemic Stroke
Presumed ischaemic stroke (i.e. not known to be haemorrhagic). Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period.
Time frame: Randomized treatment phase during median follow-up period of 4.1years
Number of Participants With Major Vascular Event
Major vascular events (defined as coronary death, myocardial infarction, coronary revascularization or presumed ischaemic stroke). Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period
Time frame: Randomized treatment phase during median follow-up period of 4.1years
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