TY - JOUR
T1 - Effect of serial infusions of reconstituted high-density lipoprotein (CER-001) on coronary atherosclerosis: rationale and design of the CARAT study
AU - Andrews, Jordan
AU - Janssan, Alex
AU - Nguyen, Tracy
AU - Pisaniello, Anthony D.
AU - Scherer, Daniel J.
AU - Kastelein, John J. P.
AU - Merkely, Bela
AU - Nissen, Steven E.
AU - Ray, Kausik
AU - Schwartz, Gregory G.
AU - Worthley, Stephen G.
AU - Keyserling, Connie
AU - Dasseux, Jean-Louis
AU - Butters, Julie
AU - Girardi, Jacinta
AU - Miller, Rosemary
AU - Nicholls, Stephen J.
PY - 2017
Y1 - 2017
N2 - 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
AB - 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
U2 - https://doi.org/10.21037/cdt.2017.01.01
DO - https://doi.org/10.21037/cdt.2017.01.01
M3 - Article
C2 - 28164012
SN - 2223-3652
VL - 7
SP - 45
EP - 51
JO - Cardiovascular diagnosis and therapy
JF - Cardiovascular diagnosis and therapy
IS - 1
ER -