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

Phase 2

Completed

• Conditions: Acute Coronary Syndromes

• Registration Number: NCT00225719
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-23
• Study First Submitted QC: 2005-09-23
• Study First Posted: 2005-09-26
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-06
• Last Update Posted: 2008-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy

Secondary Outcome Measures

Name	Time	Method
Safety

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada