CER-001 Atherosclerosis Regression ACS Trial

Study Overview
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Brief Summary
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The purpose of this study is to assess the impact of ten intravenous infusions of 3 mg/kg CER 001 vs. placebo, given at weekly intervals for ten weeks, on atherosclerotic plaque volume as measured by coronary IVUS, when administered to subjects presenting with Acute Coronary Syndrome (ACS) with significant plaque volume.

Detailed Description
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Subjects will be required to have at least one epicardial coronary artery suitable for IVUS imaging. A suitable target artery for IVUS imaging will be determined at baseline as having stenosis of up to 50% and meeting all angiographic inclusion criteria. Subjects having met all eligibility criteria will be randomized to receive an intravenous infusion of CER 001 (3 mg/kg) or placebo within 14 days of event presentation. Randomized subjects will then return at 7 day intervals for nine additional infusions. A follow up IVUS will be conducted at 14 days after the last infusion. The total study duration from randomization to follow up IVUS for a completed study can range from approximately 9 to 12 weeks.

Official Title
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CER-001 Atherosclerosis Regression ACS Trial; A Phase II Multi-Center, Double-Blind, Placebo-Controlled, Dose-Focusing Trial Of Cer-001 In Subjects With Acute Coronary Syndrome

Conditions
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Acute Coronary Syndromes

Intervention / Treatment
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* Drug: CER-001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female greater than 18 years of age Acute coronary syndrome (myocardial infarction or unstable agina) Angiographic evidence of coronary artery disease with suitable target coronary artery for IVUS evaluation Exclusion Criteria: Females of child-bearing potential Angiographic evidence of >50% stenosis of the left main artery Uncontrolled diabetes (HbA1C>10%) Hypertriglyceridemia (>500 mg/dL) Congestive heart failure (NYHA class III or IV) Ejection fraction <35% Uncontrolled hypertension (SBP >180 mm Hg) Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CER-001<br>CER-001 infusion | Drug: CER-001<br>* Engineered pre-beta HDL particle<br>* Other names: CAS 1383435-67-3;|
| Placebo Comparator: Placebo<br>Placebo infusion | Drug: Placebo<br>* Normal saline<br>* Other names: Placebo for CER-001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nominal Change in Percent Atheroma Volume (PAV) | The nominal change from baseline to follow-up (at 12 weeks) in the percent atheroma volume (PAV) in the target coronary artery assessed by 3 dimensional (3D) IVUS | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nominal Change in Normalized Total Atheroma Volume (TAV) |  | Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACS, IVUS, HDL