THE ERASE TRIAL

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rim Halaby, M.D. [2]

Click here to download slides for ERASE Trial.

Official Title

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

Objective

To study the effects of reconstituted HDL on atheromatous plaque volume as assessed by intravascular ultrasound (IVUS).

Sponsor

CSL Limited

Timeline

Timeline
Start Date	July 2005
End Date	Not provided
Status	Completed

The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT00225719.

Study Description

Study Description
Study Type	Interventional
Study Phase	Phase 2
Study Design
Allocation	Randomized
Endpoint	Safety/efficacy study
Interventional Model	Parallel assignment
Masking	Double-blind
Study Details
Primary Purpose	Treatment
Condition	Acute coronary syndromes
Intervention	Drug: rHDL
Study Arms	60 patients receiving placebo, defined as normal saline infusion 111 patients receiving CSL-111 infusion at a dose of 40 mg/kg 12 patients receiving CSL-111 infusion at a dose of 80 mg/kg Therapy was required to take place within 2 weeks of an acute coronary syndrome. Before infusion, baseline IVUS of target coronary artery using 40-MHz catheters was performed and need to fulfill the following conditions: Proximal 4 cm needed to have a reference diameter of at least 2.5 mm No filling defects of thrombotic nature No reduced luminal diameter by 50% or more according to angiographic estimation at baseline No previous percutaneous coronary intervention (PCI) Not a previous candidate for intervention at time of the baseline catheterization. Patients received 4 weekly volume-matched infusions; but infusions can be postponed for 1 week on a maximum of 2 consecutive occasions if liver transaminases were > 1.5 times the upper normal limit. Follow-up IVUS at the same target artery segment occurred 2-3 weeks after last infusion: 47 patients of placebo group had baseline and follow-up IVUS 89 patients of CSL-111 40 mg/kg group had baseline and follow-up IVUS 9 patients of CSL-111 80 mg/kg group had baseline and follow-up IVUS
Population Size	180

The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT00225719.

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

• Patients with > 50% stenosis in left main coronary artery
• Renal insufficiency
• Liver or hepatic disease
• Uncontrolled diabetes mellitus
• Symptomatic heart failure of NYHA class III or IV
• Soybean allergy (component of CSL-111 infusion)
• History of alcohol or drug abuse
• Warfarin or heparin anticoagulation during infusion period

Outcomes

Primary Outcomes

Percentage difference in volume of atheroma between follow-up and baseline on IVUS.

Secondary Outcomes

Absolute change in coronary score, defined as the mean of minimal lumen diameter for all measured lesions on angiography, and change in plaque volume and characterization on IVUS.

Publications

Results

After 4 weeks of infusion, plaque volume changes was not significantly different among the placebo and CSL-111 groups combined (p=0.48). There was a significant change in atheroma volume in both groups when compared to baseline volume(-1.62% in placebo (p=0.07) and -3.41% in CSL-111 40 mg/kg (p<0.001), but the change was not significant when comparing different groups to each other (p=0.39).

There was a significant difference in plaque characterization index on IVUS where index showed -0.0097 for CSL-111 vs. 0.0128 for placebo(p=0.01). Similarly, mean differences of angiographic coronary scores were also significnat whereby mean score change was =0.039 mm for CSL-111 vs. -0.071 mm in placebo (p=0.03).

The safety of CSL-111 was well-studied. Generally, CSL-111 was well tolerated with mild-moderate adverse events only with no varying rates between CSL-111 treatment and placebo groups except in rates of hypotension (13.8% vs. 7.1%, respectively). Elevation in liver function tests, especially after 24 hours of infusion, were all subclinical events that later normalized with no intervention. Notably, there was also a self-limited increase in unconjugated bilirubin.

Conclusion

Short-term CSL-111 infusions showed significant improvement in plaque characterization index and coronary score on angiography, but did not yield significant changes in plaque or atheroma volume. Clinically, the importance of these findings is still poorly outlined.