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

This study has been completed.

First Received on September 23, 2005. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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: Atherosclerosis 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 ClinicalTrials.gov Identifier (NCT Number):

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

Additional relevant MeSH terms:

Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris

Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012