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NCT00225719 Clinical Trial

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

Acute Coronary Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00225719
Other study ID # CSLCT-HDL-04-06
Secondary ID
Status Completed
Phase Phase 2
First received September 23, 2005
Last updated November 6, 2008
Start date July 2005

Study information
Verified date November 2008
Source CSL Limited
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• rHDL

Locations
Country Name City State
Canada Montreal Heart Institute Montreal Quebec

Sponsors (1)
Lead Sponsor Collaborator
CSL Limited

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy
Secondary Safety
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