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

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

This study has been completed.
Information provided by CSL Limited

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Efficacy

Secondary Outcome Measure ^†

Safety

Condition ^†

Acute Coronary Syndromes

Intervention ^†

Drug: rHDL

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

180

Start Date ^†

July 2005

Completion Date

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

Gender

Both

Ages

30 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Canada

Administrative Information Fields

NCT ID ^†

NCT00225719

Organization ID

CSLCT-HDL-04-06

Secondary IDs ^††

Study Sponsor ^†

CSL Limited

Collaborators ^††

Investigators ^†

Principal Investigator:

Jean-Claude Tardif, MD FRCP

Montreal Heart Institute

Information Provided By

CSL Limited

Verification Date

May 2007

First Received Date ^†

September 23, 2005

Last Updated Date

May 28, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.