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

This study has been completed.

First Received: September 23, 2005 Last Updated: November 6, 2008 History of Changes

Sponsor:	CSL Limited
Information provided by:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00225719

Purpose

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).

Condition	Intervention	Phase
Acute Coronary Syndromes	Drug: rHDL	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Regression of Coronary Atherosclerotic Lesions After rHDL Infusions in Acute Coronary Syndrome Patients as Assessed by Intravascular Ultrasound.

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

Further study details as provided by CSL Limited:

Primary Outcome Measures:

Efficacy

Secondary Outcome Measures:

Safety

Estimated Enrollment:	180
Study Start Date:	July 2005

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female 30 - 75 years of age
Recent acute coronary syndrome, defined as unstable angina, non-Q wave myocardial infarction, or ST elevation indicative of myocardial infarction, within the last 14 days

Exclusion Criteria:

>50% stenosis by visual angiographic estimation in the left main artery
Renal insufficiency
Severe liver disease
Congestive heart failure as defined by the NYHA classification as functional Class III or Class IV
Previous or planned coronary artery bypass surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225719

Locations

Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8

Sponsors and Collaborators

CSL Limited

Investigators

Principal Investigator:

Jean-Claude Tardif, MD FRCP

Montreal Heart Institute

More Information

No publications provided by CSL Limited

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2007 Mar 26.

Responsible Party:	CSL Limited ( Dr Russell Basser )
Study ID Numbers:	CSLCT-HDL-04-06
Study First Received:	September 23, 2005
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00225719 History of Changes
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Heart Diseases
Pathologic Processes
Disease
Myocardial Ischemia

Syndrome
Acute Coronary Syndrome
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2009