NCT02586155

Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD

A Phase III Multi-Center, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Clinical Trial in High-Risk Type 2 Diabetes Mellitus (T2DM) Subjects With Coronary Artery Disease (CAD) to Determine Whether Bromodomain Extraterminal Domain (BET) Inhibition Treatment With RVX000222 Increases the Time to Major Adverse Cardiovascular Events (MACE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,425 (actual)
• Sponsor: Resverlogix Corp · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether bromodomain extraterminal domain (BET) inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with coronary artery disease increases the time to major adverse cardiovascular events.

Detailed description

The majority (75%) of deaths in subjects with diabetes mellitus (DM) are due to atherosclerotic cardiovascular disease (CVD). Recent studies suggest a major adverse cardiovascular event (MACE) rate of \>11% over 18 months in type 2 diabetes mellitus (T2DM) despite a baseline LDL-C of \<2.1 mmol/L. Bromodomains (BRDs) are a family of evolutionary conserved protein-interaction modules that play key functions in chromatin organization and regulation of gene transcription. One recognized family of bromodomain-containing proteins is the bromodomain and extra-terminal (BET) family. BET inhibition represents a novel, epigenetic approach to treat CAD. RVX000222 affects biological processes important in atherosclerosis and acute coronary events via selective inhibition of BET proteins. RVX000222 is available as a capsule formulation with standard excipients and established stability. The BETonMACE study will focus on prevention of subsequent MACE in subjects with CAD and DM with high intensity statin therapy as co-medication.

Conditions

• Diabetes Mellitus, Type 2
• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Apabetalone	100 mg capsule
DRUG	Placebo	Capsule manufactured to mimic RVX000222 100 mg capsule
DRUG	Atorvastatin	High-Intensity Statin
DRUG	Rosuvastatin	High-Intensity Statin

Timeline

• Start date: 2015-11-01
• Primary completion: 2020-11-30
• Completion: 2021-06-21
• First posted: 2015-10-26
• Last updated: 2021-08-20
• Results posted: 2021-08-20

Locations

214 sites across 15 countries: Argentina, Australia, Belgium, Bulgaria, Croatia, Germany, Hungary, Israel, Mexico, Netherlands, Poland, Russia, Serbia, Slovakia, Taiwan

Regulatory

• FDA-regulated drug study