CER-001 Atherosclerosis Regression ACS Trial

Last updated: February 6, 2019
Sponsor: Cerenis Therapeutics, SA
Overall Status: Completed

Phase

2

Condition

Chest Pain

Myocardial Ischemia

Heart Disease

Treatment

N/A

Clinical Study ID

NCT02484378
CER-001-CLIN-010
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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" coronaryartery for IVUS evaluation

Exclusion

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 endocrinedysfunction

Study Design

Total Participants: 301
Study Start date:
August 01, 2015
Estimated Completion Date:
December 31, 2016

Study 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.

Connect with a study center

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford park, South Australia 5042
    Australia

    Site Not Available

  • Queen Elizabeth Hospital

    Woodville South, South Australia 5011
    Australia

    Site Not Available

  • Peninsula Heart Centre

    Frankston, Victoria 3199
    Australia

    Site Not Available

  • Epworth Research Institute

    Richmond, Victoria 3121
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, Western Australia 6001
    Australia

    Site Not Available

  • Military Hospital

    Budapest, 1134
    Hungary

    Site Not Available

  • Semmelweiss University

    Budapest, 1122
    Hungary

    Site Not Available

  • University of Debrecen

    Debrecen, 4000
    Hungary

    Site Not Available

  • Pándy Kálmán County Hospital

    Gyula, 5700
    Hungary

    Site Not Available

  • County Hospital of Kecskemet

    Kecskemet, 6000
    Hungary

    Site Not Available

  • University of Szeged

    Szeged, 6725
    Hungary

    Site Not Available

  • Meander Medisch Centrum

    Amersfoort, 3813TZ
    Netherlands

    Site Not Available

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC
    Netherlands

    Site Not Available

  • Scheper Ziekenhuis

    Emmen, 7824AA
    Netherlands

    Site Not Available

  • Medisch Centrum Haaglanden

    Leidschendam, 2262BA
    Netherlands

    Site Not Available

  • Canisius-Wilhelmina hospital

    Nijmegen, 6532 SZ
    Netherlands

    Site Not Available

  • Maasstad Hospital

    Rotterdam, 3079 DZ
    Netherlands

    Site Not Available

  • Twee Steden hospital (Tilburg)

    Tilburg, 5042 AD
    Netherlands

    Site Not Available

  • VieCuri Medisch Centrum

    Venlo, 5912 BL
    Netherlands

    Site Not Available

  • Heart Center Research, LLC

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • VA San Diego Healthcare System

    San Diego, California 92161
    United States

    Site Not Available

  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • VA Eastern Colorado Health Care System

    Denver, Colorado 80220
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Cardiovascular Associates Research LLC

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Cardiac and Vascular Research Center of Northern Michigan

    Petoskey, Michigan 49770
    United States

    Site Not Available

  • University of Missouri Health System

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Buffalo Heart Group LLP

    Buffalo, New York 14215
    United States

    Site Not Available

  • Veterans Affairs WNY Healthcare System

    Buffalo, New York 14215
    United States

    Site Not Available

  • Novant Health Heart and Vascular Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • South Oklahoma Heart Research, LLC

    Oklahoma City, Oklahoma 73135
    United States

    Site Not Available

  • Dallas VA Medical Center

    Dallas, Texas 75216
    United States

    Site Not Available

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