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CER-001 Atherosclerosis Regression ACS Trial (CARAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02484378
Recruitment Status : Completed
First Posted : June 29, 2015
Last Update Posted : February 11, 2019
Sponsor:
Collaborator:
South Australian Health and Medical Research Institute
Information provided by (Responsible Party):
Cerenis Therapeutics, SA

Tracking Information
First Submitted Date  ICMJE June 25, 2015
First Posted Date  ICMJE June 29, 2015
Last Update Posted Date February 11, 2019
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2015)
Nominal Change in Normalized Total Atheroma Volume (TAV) [ Time Frame: Baseline to 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 26, 2015)
  • 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.
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE CER-001 Atherosclerosis Regression ACS Trial
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndromes
Intervention  ICMJE
  • Drug: CER-001
    Engineered pre-beta HDL particle
    Other Name: CAS 1383435-67-3
  • Drug: Placebo
    Normal saline
    Other Name: Placebo for CER-001
Study Arms  ICMJE
  • Experimental: CER-001
    CER-001 infusion
    Intervention: Drug: CER-001
  • Placebo Comparator: Placebo
    Placebo infusion
    Intervention: Drug: Placebo
Publications * 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-β 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2016)
301
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2015)
292
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Hungary,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02484378
Other Study ID Numbers  ICMJE CER-001-CLIN-010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: to be determined.
Responsible Party Cerenis Therapeutics, SA
Study Sponsor  ICMJE Cerenis Therapeutics, SA
Collaborators  ICMJE South Australian Health and Medical Research Institute
Investigators  ICMJE
Study Director: Connie Keyserling, MS Cerenis Therapeutics
Study Chair: Stephen Nicholls, MD PhD South Australian Health and Medical Research Institute
PRS Account Cerenis Therapeutics, SA
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP