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Completed

NCT Number: NCT02484378

CER-001 Atherosclerosis Regression ACS Trial

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.

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Concord Repatriation General Hospital, Concord, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CER-001

Drug

Engineered pre-beta HDL particle

Other names: CAS 1383435-67-3

Placebo

Drug

Normal saline

Other names: Placebo for CER-001

Primary outcomes

  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 outcomes

  1. Nominal Change in Normalized Total Atheroma Volume (TAV)

    Time frame: Baseline to 12 weeks

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Cerenis Therapeutics, SA

Industry

Collaborators

  • South Australian Health and Medical Research Institute

Registry information

Official study 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

Acronym: CARAT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2015
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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