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| Name | Class |
|---|---|
| South Australian Health and Medical Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CER-001 | Experimental | CER-001 infusion |
|
| Placebo | Placebo Comparator | Placebo infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CER-001 | Drug | Engineered pre-beta HDL particle |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Nominal Change in Percent Atheroma Volume (PAV) | 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 | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Nominal Change in Normalized Total Atheroma Volume (TAV) | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Major Cardiovascular Events (MACE) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Connie Keyserling, MS | Cerenis Therapeutics | Study Director |
| Stephen Nicholls, MD PhD | South Australian Health and Medical Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC | Huntsville | Alabama | 35801 | United States | ||
| VA San Diego Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30046828 | Derived | Nicholls SJ, Andrews J, Kastelein JJP, Merkely B, Nissen SE, Ray KK, Schwartz GG, Worthley SG, Keyserling C, Dasseux JL, Griffith L, Kim SW, Janssan A, Di Giovanni G, Pisaniello AD, Scherer DJ, Psaltis PJ, Butters J. Effect of Serial Infusions of CER-001, a Pre-beta High-Density Lipoprotein Mimetic, on Coronary Atherosclerosis in Patients Following Acute Coronary Syndromes in the CER-001 Atherosclerosis Regression Acute Coronary Syndrome Trial: A Randomized Clinical Trial. JAMA Cardiol. 2018 Sep 1;3(9):815-822. doi: 10.1001/jamacardio.2018.2121. |
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to be determined.
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| Placebo | Drug | Normal saline |
|
|
| 12 weeks |
| Lipid Profiles | 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 | Throughout the 12 week study period |
| San Diego |
| California |
| 92161 |
| United States |
| Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| VA Eastern Colorado Health Care System | Denver | Colorado | 80220 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Cardiovascular Associates Research LLC | Covington | Louisiana | 70433 | United States |
| Cardiac and Vascular Research Center of Northern Michigan | Petoskey | Michigan | 49770 | United States |
| University of Missouri Health System | Columbia | Missouri | 65212 | United States |
| Buffalo Heart Group LLP | Buffalo | New York | 14215 | United States |
| Veterans Affairs WNY Healthcare System | Buffalo | New York | 14215 | United States |
| Novant Health Heart and Vascular Institute | Charlotte | North Carolina | 28204 | United States |
| South Oklahoma Heart Research, LLC | Oklahoma City | Oklahoma | 73135 | United States |
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Queen Elizabeth Hospital | Woodville South | South Australia | 5011 | Australia |
| Peninsula Heart Centre | Frankston | Victoria | 3199 | Australia |
| Epworth Research Institute | Richmond | Victoria | 3121 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6001 | Australia |
| Semmelweiss University | Budapest | 1122 | Hungary |
| Military Hospital | Budapest | 1134 | Hungary |
| University of Debrecen | Debrecen | 4000 | Hungary |
| Pándy Kálmán County Hospital | Gyula | 5700 | Hungary |
| County Hospital of Kecskemet | Kecskemét | 6000 | Hungary |
| University of Szeged | Szeged | 6725 | Hungary |
| Meander Medisch Centrum | Amersfoort | 3813TZ | Netherlands |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091 AC | Netherlands |
| Scheper Ziekenhuis | Emmen | 7824AA | Netherlands |
| Medisch Centrum Haaglanden | Leidschendam | 2262BA | Netherlands |
| Canisius-Wilhelmina hospital | Nijmegen | 6532 SZ | Netherlands |
| Maasstad Hospital | Rotterdam | 3079 DZ | Netherlands |
| Twee Steden hospital (Tilburg) | Tilburg | 5042 AD | Netherlands |
| VieCuri Medisch Centrum | Venlo | 5912 BL | Netherlands |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C000591544 | CER-001 |
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