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

CSL Limited

Status and phase

Completed

Phase 2

Conditions

Acute Coronary Syndromes

Treatments

Drug: rHDL

Study type

Interventional

Funder types

Industry

Identifiers

NCT00225719

CSLCT-HDL-04-06

Details and patient eligibility

About

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).

Enrollment

180 estimated patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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