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OpenTrials
Completed

NCT Number: NCT00225719

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

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).

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rHDL

Drug

Primary outcomes

  1. Efficacy

Secondary outcomes

  1. Safety

Sponsors and collaborators

Lead sponsor

CSL Limited

Industry

Registry information

Official study title

Regression of Coronary Atherosclerotic Lesions After rHDL Infusions in Acute Coronary Syndrome Patients as Assessed by Intravascular Ultrasound.

Important dates

Study start
2005
First posted
Sep 26, 2005
Registry last updated
Nov 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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