CER-001 Atherosclerosis Regression ACS Trial
- Registration Number
- NCT02484378
- Lead Sponsor
- Cerenis Therapeutics, SA
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 301
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo infusion CER-001 CER-001 CER-001 infusion
- Primary Outcome Measures
Name Time Method Nominal Change in Percent Atheroma Volume (PAV) Baseline to 12 weeks 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
- Secondary Outcome Measures
Name Time Method Nominal Change in Normalized Total Atheroma Volume (TAV) Baseline to 12 weeks
Trial Locations
- Locations (35)
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
VA San Diego Healthcare System
🇺🇸San Diego, California, United States
Scheper Ziekenhuis
🇳🇱Emmen, Netherlands
VieCuri Medisch Centrum
🇳🇱Venlo, Netherlands
Veterans Affairs WNY Healthcare System
🇺🇸Buffalo, New York, United States
Maasstad Hospital
🇳🇱Rotterdam, Netherlands
Cardiac and Vascular Research Center of Northern Michigan
🇺🇸Petoskey, Michigan, United States
Epworth Research Institute
🇦🇺Richmond, Victoria, Australia
Pándy Kálmán County Hospital
🇭🇺Gyula, Hungary
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Flinders Medical Centre
🇦🇺Bedford park, South Australia, Australia
Canisius-Wilhelmina hospital
🇳🇱Nijmegen, Netherlands
Cardiovascular Associates Research LLC
🇺🇸Covington, Louisiana, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
University of Szeged
🇭🇺Szeged, Hungary
South Oklahoma Heart Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States
VA Eastern Colorado Health Care System
🇺🇸Denver, Colorado, United States
University of Missouri Health System
🇺🇸Columbia, Missouri, United States
Novant Health Heart and Vascular Institute
🇺🇸Charlotte, North Carolina, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Meander Medisch Centrum
🇳🇱Amersfoort, Netherlands
Medisch Centrum Haaglanden
🇳🇱Leidschendam, Netherlands
Twee Steden hospital (Tilburg)
🇳🇱Tilburg, Netherlands
Buffalo Heart Group LLP
🇺🇸Buffalo, New York, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
University of Debrecen
🇭🇺Debrecen, Hungary
Peninsula Heart Centre
🇦🇺Frankston, Victoria, Australia
Semmelweiss University
🇭🇺Budapest, Hungary
County Hospital of Kecskemet
🇭🇺Kecskemet, Hungary
Military Hospital
🇭🇺Budapest, Hungary