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

CSL Limited1 site in 1 country180 target enrollmentJuly 2005

ConditionsAcute Coronary Syndromes

DrugsrHDL

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Acute Coronary Syndromes
Sponsor: CSL Limited
Enrollment: 180
Locations: 1
Primary Endpoint: Efficacy
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

TBD

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CSL Limited

Eligibility 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