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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Acute Coronary Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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rHDL

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No