CER-001 Atherosclerosis Regression ACS Trial

Acute Coronary Syndromes Clinical Trial

— CARAT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484378
• Other study ID #: CER-001-CLIN-010
• Status: Completed
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Cerenis Therapeutics, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Atherosclerosis
• Syndrome

Intervention

Drug:
• CER-001
Engineered pre-beta HDL particle
• Placebo
Normal saline

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Flinders Medical Centre	Bedford park	South Australia
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Peninsula Heart Centre	Frankston	Victoria
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Epworth Research Institute	Richmond	Victoria
Australia	Queen Elizabeth Hospital	Woodville South	South Australia
Hungary	Military Hospital	Budapest
Hungary	Semmelweiss University	Budapest
Hungary	University of Debrecen	Debrecen
Hungary	Pándy Kálmán County Hospital	Gyula
Hungary	County Hospital of Kecskemet	Kecskemet
Hungary	University of Szeged	Szeged
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Scheper Ziekenhuis	Emmen
Netherlands	Medisch Centrum Haaglanden	Leidschendam
Netherlands	Canisius-Wilhelmina hospital	Nijmegen
Netherlands	Maasstad Hospital	Rotterdam
Netherlands	Twee Steden hospital (Tilburg)	Tilburg
Netherlands	VieCuri Medisch Centrum	Venlo
United States	Buffalo Heart Group LLP	Buffalo	New York
United States	Veterans Affairs WNY Healthcare System	Buffalo	New York
United States	Novant Health Heart and Vascular Institute	Charlotte	North Carolina
United States	University of Missouri Health System	Columbia	Missouri
United States	Cardiovascular Associates Research LLC	Covington	Louisiana
United States	Dallas VA Medical Center	Dallas	Texas
United States	VA Eastern Colorado Health Care System	Denver	Colorado
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	South Oklahoma Heart Research, LLC	Oklahoma City	Oklahoma
United States	Cardiac and Vascular Research Center of Northern Michigan	Petoskey	Michigan
United States	VA San Diego Healthcare System	San Diego	California
United States	Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Cerenis Therapeutics, SA	South Australian Health and Medical Research Institute

Countries where clinical trial is conducted

United States,  Australia,  Hungary,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 weeks
Other	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
Primary	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
Secondary	Nominal Change in Normalized Total Atheroma Volume (TAV)		Baseline to 12 weeks