Effect of CER-001 on Atherosclerosis in Acute Coronary Syndrome (ACS) Patients - Efficacy and Safety: The CHI SQUARE Trial

Study Overview
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Brief Summary
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Cardiovascular disease remains the most pressing healthcare issue for developed countries and is becoming so for developing countries. There are a number of chronic therapies available for long-term management of risk. Short term therapies for subjects with an acute event, such as an episode of acute coronary syndrome (ACS), are focused on reperfusion and removing thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a different site. There are no approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions that could lead to atherosclerotic plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. This study will assess the effects of CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by intravascular ultrasound (IVUS) measurements in patients with (ACS).

Official Title
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CHI SQUARE: Can HDL Infusions Significantly Quicken Atherosclerosis Regression? A Phase II, Multi-Center, Double-Blind, Ascending Dose, Placebo-Controlled, Dose-Finding Trial of CER-001 or Placebo in Subjects With Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female less than 75 years of age Acute coronary syndrome (acute chest pain and a diagnosis of ST segment elevation myocardial infarction, non-ST elevation myocardial infarction or unstable angina) Angiographic evidence of coronary artery disease with suitable target coronary artery for IVUS evaluation Exclusion Criteria: Females of child-bearing potential Weight >120 kg 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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Maximum Age: 75 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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Weekly injection<br>|
| Experimental: Low Dose<br>CER-001 Low Dose | Drug: CER-001<br>* Weekly injection<br>|
| Experimental: Mid Dose<br>CER-001 Mid Dose | Drug: CER-001<br>* Weekly injection<br>|
| Experimental: High Dose<br>CER-001 High Dose | Drug: CER-001<br>* Weekly injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Plaque Volume | Absolute change in total plaque volume, as assessed by IVUS, from the baseline measurement to the follow-up taken  3 weeks following the final dose of study medication (approximately 9 weeks after the baseline assessment) | Baseline and 3 weeks post final dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Plaque Volume | Percent change in total plaque volume, as assessed by IVUS, from the baseline measurement to the follow-up taken  3 weeks following the final dose of study medication (approximately 9 weeks after the baseline assessment) | Baseline and 3 weeks post final dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute coronary syndrome, HDL mimetic, ApoA-I