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

Phase 2CompletedNCT01201837

Cerenis Therapeutics, SA507 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

507

Conditions

Acute Coronary Syndrome

Interventions

Eligibility

Sex: ALLMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (47)

Heart Center Research LLC

Huntsville, Alabama, United States

Mayo Clinic - Arizona

Phoenix, Arizona, United States

VA San Diego Health Care Center

San Diego, California, United States

Palm Beach Heart Institute, LLC - Zasa Clinical Research

Boynton Beach, Florida, United States

Heart and Vascular Institute of Florida

Clearwater, Florida, United States

Outcomes

Primary Outcomes

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)

Time frame: Baseline and 3 weeks post final dose

Secondary Outcomes

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)

Time frame: Baseline and 3 weeks post final dose