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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00225719
First Posted: September 26, 2005
Last Update Posted: November 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
CSL Limited
September 23, 2005
September 26, 2005
November 10, 2008
July 2005
Not Provided
Efficacy
Same as current
Complete list of historical versions of study NCT00225719 on ClinicalTrials.gov Archive Site
Safety
Same as current
Not Provided
Not Provided
 
Effect of rHDL on Atherosclerosis - Safety and Efficacy: THE ERASE TRIAL
Regression of Coronary Atherosclerotic Lesions After rHDL Infusions in Acute Coronary Syndrome Patients as Assessed by Intravascular Ultrasound.
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Acute Coronary Syndromes
Drug: rHDL
Not Provided
Tardif JC, Grégoire J, L'Allier PL, Ibrahim R, Lespérance J, Heinonen TM, Kouz S, Berry C, Basser R, Lavoie MA, Guertin MC, Rodés-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
Not Provided
Not Provided

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
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00225719
CSLCT-HDL-04-06
Not Provided
Not Provided
Not Provided
Dr Russell Basser, CSL Limited
CSL Limited
Not Provided
Principal Investigator: Jean-Claude Tardif, MD FRCP Montreal Heart Institute
CSL Limited
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP