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)
Palm Beach Heart Institute, LLC - Zasa Clinical Research
🇺🇸Boynton Beach, Florida, United States
LeBauer Cardiovascular Research Foundation
🇺🇸Greensboro, North Carolina, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
London Health Sciences Center
🇨🇦London, Ontario, Canada
MultiCare Health System Research Institute / Cardiac Study Center
🇺🇸Tacoma, Washington, United States
Heart Center Research LLC
🇺🇸Huntsville, Alabama, United States
Buffalo Cardiology & Pulmonary Associates
🇺🇸Williamsville, New York, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
Centre Hospitalier Universitaire de Toulouse Rangueil
🇫🇷Toulouse, France
Buffalo Heart Group
🇺🇸Buffalo, New York, United States
Academic Medical Center
🇳🇱Amsterdam, AZ, Netherlands
Clinique Pasteur
🇫🇷Toulouse, France
Saint Joseph Research Institute
🇺🇸Atlanta, Georgia, United States
The Care Group, LLC
🇺🇸Indianapolis, Indiana, United States
Heart and Vascular Institute of Florida
🇺🇸Clearwater, Florida, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
St. John Health Center
🇨🇦St. John's, Newfoundland and Labrador, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
CSSS du Nord de Lanaudière
🇨🇦St-Charles-Borromée, Quebec, Canada
Hôpital Cardiologique du Haut-Lévesque
🇫🇷Bordeaux, PESSAC Cedex, France
Institut Universitaire de Cardiologie et Pneumologie de Québec (IUCPQ)
🇨🇦Quebec, Canada
Onze Lieve Vrouwe Gasthius
🇳🇱Amsterdam, AC, Netherlands
Maassstadziekenhuis Cardiology Research
🇳🇱Rotterdam, DZ, Netherlands
Canisius Wilhelmina Ziekenhuis
🇳🇱Nijmegen, SZ, Netherlands
Sanford Heart Center
🇺🇸Fargo, North Dakota, United States
Mayo Clinic - Arizona
🇺🇸Phoenix, Arizona, United States
VA San Diego Health Care Center
🇺🇸San Diego, California, United States
Detroit Medical Center (DMC) Cardiovascular Institute
🇺🇸Detroit, Michigan, United States
Suburban Hospital
🇺🇸Bethesda, Maryland, United States
Alegent Research Center
🇺🇸Omaha, Nebraska, United States
South Oklahoma Heart Research
🇺🇸Oklahoma City, Oklahoma, United States
Montreal General Hospital Research Institute
🇨🇦Montreal, Quebec, Canada
Catharina Ziekenhuis Eindhoven
🇳🇱Eindhoven, EJ, Netherlands
Centre Hospitalier Régional de Trois-Rivières
🇨🇦Trois-Rivières, Quebec, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Medisch Centrum Alkmaar
🇳🇱Alkmaar, Amsterdam, Netherlands
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
Centre de Santé et de Services Sociaux de Laval
🇨🇦Laval, Quebec, Canada
Victoria Heart Institute Foundation
🇨🇦Victoria, British Columbia, Canada
Medisch Spectrum Twente
🇳🇱Enschede, ER, Netherlands
Cardiac and Vascular Research Center of Northern Michigan
🇺🇸Petoskey, Michigan, United States
Sanford Research / USD
🇺🇸Sioux Falls, South Dakota, United States
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, AD, Netherlands
St. Antonius Ziekenhuis Nieuwegein
🇳🇱Nieuwegein, CM, Netherlands
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
University of North Carolina Medical Center
🇺🇸Chapel Hill, North Carolina, United States