Effect of serial infusions of reconstituted high-density lipoprotein (CER-001) on coronary atherosclerosis: rationale and design of the CARAT study.

Abstract

BACKGROUND:

High-density lipoprotein (HDL) is believed to have atheroprotective properties, but an effective HDL-based therapy remains elusive. Early studies have suggested that infusion of reconstituted HDL promotes reverse cholesterol transport and vascular reactivity. The CER-001 Atherosclerosis Regression Acute Coronary Syndrome Trial (CARAT) is investigating the impact of infusing an engineered pre-beta HDL mimetic containing sphingomyelin (SM) and dipalmitoyl phosphatidlyglycerol (CER-001) on coronary atheroma volume in patients with a recent acute coronary syndrome (ACS).

METHODS:

The CARAT is a phase 2, multicenter trial in which 292 patients with an ACS undergoing intracoronary ultrasonography and showing percent atheroma volume (PAV) greater than 30% are randomly assigned to treatment with ten infusions of CER-001 3 mg/kg or matching placebo, administered at weekly intervals. Intracoronary ultrasonography is repeated at the end of the treatment period.

RESULTS:

The primary endpoint is the nominal change in PAV. Safety and tolerability will also be evaluated.

CONCLUSIONS:

CARAT will establish whether serial 3 mg/kg infusions of an engineered pre-beta HDL mimetic containing SM and dipalmitoyl phosphatidlyglycerol (CER-001) will regress atherosclerotic plaque in patients with a recent ACS.

• Authors: Jordan Andrews, Alex Janssan, Tracy Nguyen, Anthony D Pisaniello, Daniel J Scherer, John J P Kastelein, Bela Merkely, Steven E Nissen, Kausik Ray, Gregory G Schwartz, Stephen G Worthley, Connie Keyserling, Jean-Louis Dasseux, Julie Butters, Jacinta Girardi, Rosemary Miller, Stephen J Nicholls
• Journal: Cardiovascular diagnosis and therapy (Cardiovasc Diagn Ther) Vol. 7 Issue 1 Pg. 45-51 (Feb 2017) ISSN: 2223-3652 [Print] China
• PMID: 28164012 (Publication Type: Journal Article)