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

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. Identifier: NCT00225719
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : November 10, 2008
Information provided by:
CSL Limited

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).

Condition or disease Intervention/treatment Phase
Acute Coronary Syndromes Drug: rHDL Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Regression of Coronary Atherosclerotic Lesions After rHDL Infusions in Acute Coronary Syndrome Patients as Assessed by Intravascular Ultrasound.
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Primary Outcome Measures :
  1. Efficacy

Secondary Outcome Measures :
  1. Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00225719

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Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
CSL Limited
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Principal Investigator: Jean-Claude Tardif, MD FRCP Montreal Heart Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Russell Basser, CSL Limited Identifier: NCT00225719    
Other Study ID Numbers: CSLCT-HDL-04-06
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: November 10, 2008
Last Verified: November 2008
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases