NCT02484378

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_2

Geographic Reach
4 countries

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 11, 2019

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

June 25, 2015

Last Update Submit

February 6, 2019

Conditions

Acute Coronary Syndromes

Keywords

ACSIVUSHDL

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline to 12 weeks

Secondary Outcomes (1)

  • Nominal Change in Normalized Total Atheroma Volume (TAV)

    Baseline to 12 weeks

Other Outcomes (2)

  • Major Cardiovascular Events (MACE)

    12 weeks

  • Lipid Profiles

    Throughout the 12 week study period

Study Arms (2)

CER-001

EXPERIMENTAL

CER-001 infusion

Drug: CER-001

Placebo

PLACEBO COMPARATOR

Placebo infusion

Drug: Placebo

Interventions

CER-001DRUG

Engineered pre-beta HDL particle

Also known as: CAS 1383435-67-3
CER-001
PlaceboDRUG

Normal saline

Also known as: Placebo for CER-001
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

Location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

VA Eastern Colorado Health Care System

Denver, Colorado, 80220, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Cardiovascular Associates Research LLC

Covington, Louisiana, 70433, United States

Location

Cardiac and Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

University of Missouri Health System

Columbia, Missouri, 65212, United States

Location

Buffalo Heart Group LLP

Buffalo, New York, 14215, United States

Location

Veterans Affairs WNY Healthcare System

Buffalo, New York, 14215, United States

Location

Novant Health Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

Location

South Oklahoma Heart Research, LLC

Oklahoma City, Oklahoma, 73135, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Queen Elizabeth Hospital

Woodville South, South Australia, 5011, Australia

Location

Peninsula Heart Centre

Frankston, Victoria, 3199, Australia

Location

Epworth Research Institute

Richmond, Victoria, 3121, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6001, Australia

Location

Semmelweiss University

Budapest, 1122, Hungary

Location

Military Hospital

Budapest, 1134, Hungary

Location

University of Debrecen

Debrecen, 4000, Hungary

Location

Pándy Kálmán County Hospital

Gyula, 5700, Hungary

Location

County Hospital of Kecskemet

Kecskemét, 6000, Hungary

Location

University of Szeged

Szeged, 6725, Hungary

Location

Meander Medisch Centrum

Amersfoort, 3813TZ, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 AC, Netherlands

Location

Scheper Ziekenhuis

Emmen, 7824AA, Netherlands

Location

Medisch Centrum Haaglanden

Leidschendam, 2262BA, Netherlands

Location

Canisius-Wilhelmina hospital

Nijmegen, 6532 SZ, Netherlands

Location

Maasstad Hospital

Rotterdam, 3079 DZ, Netherlands

Location

Twee Steden hospital (Tilburg)

Tilburg, 5042 AD, Netherlands

Location

VieCuri Medisch Centrum

Venlo, 5912 BL, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 30046828DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

CER-001

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Connie Keyserling, MS

    Cerenis Therapeutics

    STUDY DIRECTOR

  • Stephen Nicholls, MD PhD

    South Australian Health and Medical Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2015

First Posted

June 29, 2015

Study Start

August 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

February 11, 2019

Record last verified: 2017-01

Locations

NL(8)HU(6)AU(8)US(13)