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

NCT ID: NCT00225719

Last Updated: 2008-11-10

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).

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

Sponsors

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CSL Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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CSL Limited

Principal Investigators

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Jean-Claude Tardif, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute

Locations

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Montreal Heart Institute

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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Tardif JC, Gregoire J, L'Allier PL, Ibrahim R, Lesperance J, Heinonen TM, Kouz S, Berry C, Basser R, Lavoie MA, Guertin MC, Rodes-Cabau J; Effect of rHDL on Atherosclerosis-Safety and Efficacy (ERASE) Investigators. Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial. JAMA. 2007 Apr 18;297(15):1675-82. doi: 10.1001/jama.297.15.jpc70004. Epub 2007 Mar 26.

Reference Type DERIVED
PMID: 17387133 (View on PubMed)

Other Identifiers

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CSLCT-HDL-04-06

Identifier Type: -

Identifier Source: org_study_id