Acute Coronary Syndromes
Conditions
Keywords
ACS, IVUS, HDL
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.
Interventions
DRUGCER-001
Engineered pre-beta HDL particle
DRUGPlacebo
Normal saline
Sponsors
South Australian Health and Medical Research Institute
Cerenis Therapeutics, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Nominal Change in Normalized Total Atheroma Volume (TAV) | Baseline to 12 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Major Cardiovascular Events (MACE) | 12 weeks | Episodes of all death, non-fatal myocardial infarction, resuscitated cardiac arrest, non-fatal stroke, fatal stroke, coronary revascularization procedures \[percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)\], hospitalization for unstable angina, urgent visit or hospitalization for congestive heart failure (CHF), any admission for a procedure for the treatment of PVD (including cerebrovascular procedures) and urgent readmission with chest pain. The events will be reviewed and adjudicated by the Clinical Endpoint Committee according to established definitions. This study is not powered for MACE endpoints. |
| Lipid Profiles | Throughout the 12 week study period | Pre-dose lipid profiles, including low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), total cholesterol (TC), unesterified cholesterol (UC), triglycerides (TG), phospholipids (PL), apolipoprotein A-I (apoA-I) and apolipoprotein B (apoB), will be determined periodically throughout the study |
Countries
Australia, Hungary, Netherlands, United States
Outcome results
None listed