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CER-001 Atherosclerosis Regression ACS Trial (CARAT)

Primary Purpose

Acute Coronary Syndromes

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CER-001
Placebo
Sponsored by
Cerenis Therapeutics, SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndromes focused on measuring ACS, IVUS, HDL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Center Research, LLC
  • VA San Diego Healthcare System
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
  • VA Eastern Colorado Health Care System
  • Jacksonville Center for Clinical Research
  • Cardiovascular Associates Research LLC
  • Cardiac and Vascular Research Center of Northern Michigan
  • University of Missouri Health System
  • Buffalo Heart Group LLP
  • Veterans Affairs WNY Healthcare System
  • Novant Health Heart and Vascular Institute
  • South Oklahoma Heart Research, LLC
  • Dallas VA Medical Center
  • Concord Repatriation General Hospital
  • Liverpool Hospital
  • Royal Adelaide Hospital
  • Flinders Medical Centre
  • Queen Elizabeth Hospital
  • Peninsula Heart Centre
  • Epworth Research Institute
  • Royal Perth Hospital
  • Semmelweiss University
  • Military Hospital
  • University of Debrecen
  • Pándy Kálmán County Hospital
  • County Hospital of Kecskemet
  • University of Szeged
  • Meander Medisch Centrum
  • Onze Lieve Vrouwe Gasthuis
  • Scheper Ziekenhuis
  • Medisch Centrum Haaglanden
  • Canisius-Wilhelmina hospital
  • Maasstad Hospital
  • Twee Steden hospital (Tilburg)
  • VieCuri Medisch Centrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CER-001

Placebo

Arm Description

CER-001 infusion

Placebo infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Nominal Change in Normalized Total Atheroma Volume (TAV)

Full Information

First Posted
June 25, 2015
Last Updated
February 6, 2019
Sponsor
Cerenis Therapeutics, SA
Collaborators
South Australian Health and Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02484378
Brief Title
CER-001 Atherosclerosis Regression ACS Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerenis Therapeutics, SA
Collaborators
South Australian Health and Medical Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes
Keywords
ACS, IVUS, HDL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CER-001
Arm Type
Experimental
Arm Description
CER-001 infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo infusion
Intervention Type
Drug
Intervention Name(s)
CER-001
Other Intervention Name(s)
CAS 1383435-67-3
Intervention Description
Engineered pre-beta HDL particle
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo for CER-001
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
Nominal Change in Percent Atheroma Volume (PAV)
Description
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
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Nominal Change in Normalized Total Atheroma Volume (TAV)
Time Frame
Baseline to 12 weeks
Other Pre-specified Outcome Measures:
Title
Major Cardiovascular Events (MACE)
Description
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.
Time Frame
12 weeks
Title
Lipid Profiles
Description
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
Time Frame
Throughout the 12 week study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie Keyserling, MS
Organizational Affiliation
Cerenis Therapeutics
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stephen Nicholls, MD PhD
Organizational Affiliation
South Australian Health and Medical Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Center Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
VA Eastern Colorado Health Care System
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Cardiovascular Associates Research LLC
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Cardiac and Vascular Research Center of Northern Michigan
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
University of Missouri Health System
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Buffalo Heart Group LLP
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Veterans Affairs WNY Healthcare System
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Novant Health Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
South Oklahoma Heart Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Peninsula Heart Centre
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Epworth Research Institute
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Semmelweiss University
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Military Hospital
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
University of Debrecen
City
Debrecen
ZIP/Postal Code
4000
Country
Hungary
Facility Name
Pándy Kálmán County Hospital
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
County Hospital of Kecskemet
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
University of Szeged
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Meander Medisch Centrum
City
Amersfoort
ZIP/Postal Code
3813TZ
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Scheper Ziekenhuis
City
Emmen
ZIP/Postal Code
7824AA
Country
Netherlands
Facility Name
Medisch Centrum Haaglanden
City
Leidschendam
ZIP/Postal Code
2262BA
Country
Netherlands
Facility Name
Canisius-Wilhelmina hospital
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Maasstad Hospital
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
Facility Name
Twee Steden hospital (Tilburg)
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
Facility Name
VieCuri Medisch Centrum
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
to be determined.
Citations:
PubMed Identifier
30046828
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.
Results Reference
derived

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CER-001 Atherosclerosis Regression ACS Trial

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