CER-001 Atherosclerosis Regression ACS Trial (CARAT)

February 6, 2019 updated by: Cerenis Therapeutics, SA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Bedford park, South Australia, Australia, 5042
        • Flinders Medical Centre
      • Woodville South, South Australia, Australia, 5011
        • Queen Elizabeth Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Peninsula Heart Centre
      • Richmond, Victoria, Australia, 3121
        • Epworth Research Institute
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Royal Perth Hospital
  • Hungary
      • Budapest, Hungary, 1122
        • Semmelweiss University
      • Budapest, Hungary, 1134
        • Military Hospital
      • Debrecen, Hungary, 4000
        • University of Debrecen
      • Gyula, Hungary, 5700
        • Pándy Kálmán County Hospital
      • Kecskemet, Hungary, 6000
        • County Hospital of Kecskemet
      • Szeged, Hungary, 6725
        • University of Szeged
  • Netherlands
      • Amersfoort, Netherlands, 3813TZ
        • Meander Medisch Centrum
      • Amsterdam, Netherlands, 1091 AC
        • Onze Lieve Vrouwe Gasthuis
      • Emmen, Netherlands, 7824AA
        • Scheper Ziekenhuis
      • Leidschendam, Netherlands, 2262BA
        • Medisch Centrum Haaglanden
      • Nijmegen, Netherlands, 6532 SZ
        • Canisius-Wilhelmina Hospital
      • Rotterdam, Netherlands, 3079 DZ
        • Maasstad Hospital
      • Tilburg, Netherlands, 5042 AD
        • Twee Steden hospital (Tilburg)
      • Venlo, Netherlands, 5912 BL
        • VieCuri Medisch Centrum
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC
    • California
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System
      • Torrance, California, United States, 90502
        • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    • Colorado
      • Denver, Colorado, United States, 80220
        • VA Eastern Colorado Health Care System
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Cardiovascular Associates Research LLC
    • Michigan
      • Petoskey, Michigan, United States, 49770
        • Cardiac and Vascular Research Center of Northern Michigan
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Health System
    • New York
      • Buffalo, New York, United States, 14215
        • Buffalo Heart Group LLP
      • Buffalo, New York, United States, 14215
        • Veterans Affairs WNY Healthcare System
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Heart and Vascular Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • South Oklahoma Heart Research, LLC
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo infusion
Drug: Placebo
Normal saline
Other Names:
  • Placebo for CER-001
Experimental: CER-001
CER-001 infusion
Drug: CER-001
Engineered pre-beta HDL particle
Other Names:
  • CAS 1383435-67-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nominal Change in Percent Atheroma Volume (PAV)
Time Frame: 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
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Nominal Change in Normalized Total Atheroma Volume (TAV)
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Cardiovascular Events (MACE)
Time Frame: 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.
12 weeks
Lipid Profiles
Time Frame: 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
Throughout the 12 week study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cerenis Therapeutics, SA

Collaborators

South Australian Health and Medical Research Institute

Investigators

  • Study Director: Connie Keyserling, MS, Cerenis Therapeutics
  • Study Chair: Stephen Nicholls, MD PhD, South Australian Health and Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER-001-CLIN-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

to be determined.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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