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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

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndromes Drug: CER-001 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
Experimental: CER-001
CER-001 infusion
Drug: CER-001
Engineered pre-beta HDL particle
Other Name: CAS 1383435-67-3

Placebo Comparator: Placebo
Placebo infusion
Drug: Placebo
Normal saline
Other Name: Placebo for CER-001




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Nominal Change in Normalized Total Atheroma Volume (TAV) [ Time Frame: Baseline to 12 weeks ]

Other Outcome Measures:
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484378


Locations
Show Show 35 study locations
Sponsors and Collaborators
Cerenis Therapeutics, SA
South Australian Health and Medical Research Institute
Investigators
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Study Director: Connie Keyserling, MS Cerenis Therapeutics
Study Chair: Stephen Nicholls, MD PhD South Australian Health and Medical Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cerenis Therapeutics, SA
ClinicalTrials.gov Identifier: NCT02484378    
Other Study ID Numbers: CER-001-CLIN-010
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: to be determined.
Keywords provided by Cerenis Therapeutics, SA:
ACS
IVUS
HDL
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Atherosclerosis
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases