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

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

Research output: Contribution to journalArticleResearchpeer-review

32 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)45-51
Number of pages7
JournalCardiovascular Diagnosis and Therapy
Volume7
Issue number1
DOIs
Publication statusPublished - 1 Jan 2017
Externally publishedYes

Keywords

  • Atherosclerosis
  • CER-001
  • Clinical trial
  • High-density lipoproteins (HDLs)
  • Intravascular ultrasound

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