Clinical trial NCT02484378: CER-001 Atherosclerosis Regression ACS Trial
Official title: CER-001 Atherosclerosis Regression ACS Trial; A Phase II Multi-Center, Double-Blind, Placebo-Controlled, Dose-Focusing Trial Of Cer-001 In Subjects With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndromes
Keywords: ACS
IVUS
HDL
Lead sponsor: Cerenis Therapeutics, SA
Sponsor class: INDUSTRY
Collaborators: name: South Australian Health and Medical Research Institute
First posted: 2015-06-29
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nominal Change in Percent Atheroma Volume (PAV)
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Nominal Change in Normalized Total Atheroma Volume (TAV)
timeFrame: Baseline to 12 weeks
Other outcomes:
measure: Major Cardiovascular Events (MACE)
timeFrame: 12 weeks
measure: Lipid Profiles
timeFrame: Throughout the 12 week study period
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
state: California
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System
state: Colorado
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Covington
country: United States
facility: Cardiovascular Associates Research LLC
state: Louisiana
city: Petoskey
country: United States
facility: Cardiac and Vascular Research Center of Northern Michigan
state: Michigan
city: Columbia
country: United States
facility: University of Missouri Health System
state: Missouri
city: Buffalo
country: United States
facility: Buffalo Heart Group LLP
state: New York
city: Buffalo
country: United States
facility: Veterans Affairs WNY Healthcare System
state: New York
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Institute
state: North Carolina
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research, LLC
state: Oklahoma
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bedford park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Woodville South
country: Australia
facility: Queen Elizabeth Hospital
state: South Australia
city: Frankston
country: Australia
facility: Peninsula Heart Centre
state: Victoria
city: Richmond
country: Australia
facility: Epworth Research Institute
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Budapest
country: Hungary
facility: Semmelweiss University
city: Budapest
country: Hungary
facility: Military Hospital
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Gyula
country: Hungary
facility: Pándy Kálmán County Hospital
city: Kecskemet
country: Hungary
facility: County Hospital of Kecskemet
city: Szeged
country: Hungary
facility: University of Szeged
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Emmen
country: Netherlands
facility: Scheper Ziekenhuis
city: Leidschendam
country: Netherlands
facility: Medisch Centrum Haaglanden
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina hospital
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Tilburg
country: Netherlands
facility: Twee Steden hospital (Tilburg)
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum
Study officials:
affiliation: Cerenis Therapeutics
name: Connie Keyserling, MS
role: STUDY_DIRECTOR
affiliation: South Australian Health and Medical Research Institute
name: Stephen Nicholls, MD PhD
role: STUDY_CHAIR
References:
citation: 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.