Back to resultsEffect of rHDL on Atherosclerosis - Safety and Efficacy: THE ERASE TRIAL
Primary Purpose
Acute Coronary Syndromes
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
rHDL
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndromes
Eligibility 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
Sites / Locations
- Montreal Heart Institute
Outcomes
Primary Outcome Measures
Efficacy
Secondary Outcome Measures
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00225719
Brief Title
Effect of rHDL on Atherosclerosis - Safety and Efficacy: THE ERASE TRIAL
Official Title
Regression of Coronary Atherosclerotic Lesions After rHDL Infusions in Acute Coronary Syndrome Patients as Assessed by Intravascular Ultrasound.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
CSL Limited
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rHDL
Primary Outcome Measure Information:
Title
Efficacy
Secondary Outcome Measure Information:
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Claude Tardif, MD FRCP
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17387133
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of rHDL on Atherosclerosis - Safety and Efficacy: THE ERASE TRIAL
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