CER-001 Atherosclerosis Regression ACS Trial

NCT ID: NCT02484378

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-12-31

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.

Conditions

Acute Coronary Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CER-001

CER-001 infusion

Group Type: EXPERIMENTAL

CER-001

Intervention Type: DRUG

Engineered pre-beta HDL particle

Placebo

Placebo infusion

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline

Interventions

CER-001

Engineered pre-beta HDL particle

Intervention Type: DRUG

Placebo

Normal saline

Intervention Type: DRUG

Other Intervention Names

CAS 1383435-67-3; Placebo for CER-001

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Australian Health and Medical Research Institute

OTHER

Sponsor Role: collaborator

Cerenis Therapeutics, SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Connie Keyserling, MS

Role: STUDY_DIRECTOR

Cerenis Therapeutics

Stephen Nicholls, MD PhD

Role: STUDY_CHAIR

South Australian Health and Medical Research Institute

Locations

Heart Center Research, LLC

Huntsville, Alabama, United States

VA San Diego Healthcare System

San Diego, California, United States

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, United States

VA Eastern Colorado Health Care System

Denver, Colorado, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Cardiovascular Associates Research LLC

Covington, Louisiana, United States

Cardiac and Vascular Research Center of Northern Michigan

Petoskey, Michigan, United States

University of Missouri Health System

Columbia, Missouri, 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

South Oklahoma Heart Research, LLC

Oklahoma City, Oklahoma, United States

Dallas VA Medical Center

Dallas, Texas, United States

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Peninsula Heart Centre

Frankston, Victoria, Australia

Epworth Research Institute

Richmond, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Semmelweiss University

Budapest, , Hungary

Military Hospital

Budapest, , Hungary

University of Debrecen

Debrecen, , Hungary

Pándy Kálmán County Hospital

Gyula, , Hungary

County Hospital of Kecskemet

Kecskemét, , Hungary

University of Szeged

Szeged, , Hungary

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, , Netherlands

Countries

United States; Australia; Hungary; Netherlands

References

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.

Reference Type: DERIVED

PMID: 30046828 (View on PubMed)

Other Identifiers

CER-001-CLIN-010

Identifier Type: -

Identifier Source: org_study_id