Effect of CER-001 on Atherosclerosis in Acute Coronary Syndrome (ACS) Patients - Efficacy and Safety: The CHI SQUARE Trial
- Registration Number
- NCT01201837
- Lead Sponsor
- Cerenis Therapeutics, SA
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 507
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Dose CER-001 CER-001 High Dose Placebo Placebo - Mid Dose CER-001 CER-001 Mid Dose Low Dose CER-001 CER-001 Low Dose
- Primary Outcome Measures
Name Time Method Change in Total Plaque Volume Baseline and 3 weeks post final dose 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)
- Secondary Outcome Measures
Name Time Method Percent Change in Plaque Volume Baseline and 3 weeks post final dose 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)
Trial Locations
- 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
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Saint Joseph Research Institute
🇺🇸Atlanta, Georgia, United States
The Care Group, LLC
🇺🇸Indianapolis, Indiana, United States
Suburban Hospital
🇺🇸Bethesda, Maryland, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Scroll for more (37 remaining)Heart Center Research LLC🇺🇸Huntsville, Alabama, United States