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

This study has been completed.
Information provided by CSL Limited

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Descriptive Information Fields
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.
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).

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Efficacy
Secondary Outcome Measure  Safety
Condition  Acute Coronary Syndromes
Intervention  Drug: rHDL
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  180
Start Date  July 2005
Completion Date
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
Gender Both
Ages 30 Years to 75 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00225719
Organization ID CSLCT-HDL-04-06
Secondary IDs ††
Study Sponsor  CSL Limited
Collaborators ††
Investigators 
Principal Investigator:     Jean-Claude Tardif, MD FRCP     Montreal Heart Institute    
Information Provided By CSL Limited
Verification Date May 2007
First Received Date  September 23, 2005
Last Updated Date May 28, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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