Effect of rHDL on Atherosclerosis - Safety and Efficacy: THE ERASE TRIAL

Phase 2 Completed 180 enrolled CSL Limited

RandomizedParallel-groupDouble-blindTreatment

Summary

Currently available therapies to treat Acute Coronary Syndromes(ACS) have several limitations including; the relatively long treatment duration required before apparent significant benefit; the inability to achieve reversal of the atherosclerotic process; and poor patient compliance due to chronicity of therapy. This study will assess the effects of rHDL compared with placebo on indices of atherosclerosis progression and regression as assessed with intravascular ultrasound (IVUS) in patients after acute coronary syndromes (ACS).

Timeline

Start: 2005-07
Primary completion: —
Completion: —

Outcome

Missed primary endpoint

paper The percentage change in atheroma volume was -3.4% with CSL-111 and -1.6% for placebo (P = .48 between groups PMID 17387133 ↗

Publications

Tardif JC, Gregoire J, L'Allier PL, Ibrahim R, Lesperance J, Heinonen TM, Kouz S, Berry C, Basser R, Lavoie MA, Guertin MC, Rodes-Cabau J; Effect of rHDL on Atherosclerosis-Safety and Efficacy (ERASE) Investigators. Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial. JAMA. 2007 Apr 18;297(15):1675-82. doi: 10.1001/jama.297.15.jpc70004. Epub 2007 Mar 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CSL-111	Unknown	40 mg/kg	Other
Subject	CSL-111	Unknown	80 mg/kg	Other