Randomized Evaluation of the Effects of Anacetrapib Through Lipid-modification (REVEAL)-A Large-scale, Randomized, Placebo-controlled Trial of the Clinical Effects of Anacetrapib Among People with Established Vascular Disease: Trial Design,...

Overview

Journal Am Heart J

Specialty Cardiology & Vascular Diseases

Date 2017 Apr 30

PMID 28454801

Citations 26

Authors

L Bowman

F Chen

E Sammons

J C Hopewell

K Wallendszus

W Stevens

E Valdes- Marquez

S Wiviott

C P Cannon

E Braunwald

R Collins

M J Landray

Affiliations

Soon will be listed here.

Abstract

Methods: The REVEAL study is a randomized, double-blind, placebo-controlled clinical trial that is assessing the efficacy and safety of adding anacetrapib to effective LDL-lowering treatment with atorvastatin for an average of at least 4years among patients with preexisting atherosclerotic vascular disease. The primary assessment is an intention-to-treat comparison among all randomized participants of the effects of allocation to anacetrapib on major coronary events (defined as the occurrence of coronary death, myocardial infarction, or coronary revascularization).

Results: Between August 2011 and October 2013, 30,449 individuals in Europe, North America, and China were randomized to receive anacetrapib 100mg daily or matching placebo. Mean (SD) age was 67 (8) years, 84% were male, 88% had a history of coronary heart disease, 22% had cerebrovascular disease, and 37% had diabetes mellitus. At the randomization visit (after at least 8weeks on a protocol-defined atorvastatin regimen), mean plasma LDL cholesterol was 61 (15) mg/dL and HDL cholesterol was 40 (10) mg/dL.

Interpretation: The REVEAL trial will provide a robust evaluation of the clinical efficacy and safety of adding anacetrapib to an effective statin regimen. Results are anticipated in 2017.

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