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

This study has been completed.
Sponsor:
Information provided by:
CSL Limited
ClinicalTrials.gov Identifier:
NCT00225719
First received: September 23, 2005
Last updated: November 6, 2008
Last verified: November 2008
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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 July 23, 2014