Acute Coronary SyndromesPhase 2CARATNCT02484378
CER-001 Atherosclerosis Regression ACS Trial
A Phase 2 study testing CER-001 in people with Acute Coronary Syndromes, run by Cerenis Therapeutics, SA at 35 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- CER-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 301 participants
- Where
- 35 sitesin 4 countries
- Study dates
- Aug 2015to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
United States13 sites
Buffalo Heart Group LLP
Buffalo, New York, 14215
Veterans Affairs WNY Healthcare System
Buffalo, New York, 14215
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204
University of Missouri Health System
Columbia, Missouri, 65212
Cardiovascular Associates Research LLC
Covington, Louisiana, 70433
Dallas VA Medical Center
Dallas, Texas, 75216
VA Eastern Colorado Health Care System
Denver, Colorado, 80220
Heart Center Research, LLC
Huntsville, Alabama, 35801
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, 73135
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770
VA San Diego Healthcare System
San Diego, California, 92161
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
Australia8 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, 5042
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Peninsula Heart Centre
Frankston, Victoria, 3199
Liverpool Hospital
Liverpool, New South Wales, 2170
Royal Perth Hospital
Perth, Western Australia, 6001
Epworth Research Institute
Richmond, Victoria, 3121
Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Netherlands8 sites
Meander Medisch Centrum
Amersfoort, 3813TZ
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 AC
Scheper Ziekenhuis
Emmen, 7824AA
Medisch Centrum Haaglanden
Leidschendam, 2262BA
Canisius-Wilhelmina hospital
Nijmegen, 6532 SZ
Maasstad Hospital
Rotterdam, 3079 DZ
Twee Steden hospital (Tilburg)
Tilburg, 5042 AD
VieCuri Medisch Centrum
Venlo, 5912 BL
Hungary6 sites
Semmelweiss University
Budapest, 1122
Military Hospital
Budapest, 1134
University of Debrecen
Debrecen, 4000
Pándy Kálmán County Hospital
Gyula, 5700
County Hospital of Kecskemet
Kecskemét, 6000
University of Szeged
Szeged, 6725
About this study
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
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.
Read the 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.
- Conditions
- Acute Coronary Syndromes
- Being tested
- CER-001, Placebo
- Keywords
- ACS, IVUS, HDL
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CER-001Drug
Also called CAS 1383435-67-3
Engineered pre-beta HDL particle
PlaceboDrug
Also called Placebo for CER-001
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| CER-001 | Experimental | CER-001 infusion Receives: Drug: CER-001 |
| Placebo | Placebo comparator | Placebo infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 12 weeks
Secondary outcomes (1)
Nominal Change in Normalized Total Atheroma Volume (TAV)
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerenis Therapeutics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- South Australian Health and Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Connie Keyserling, MS, Study director, Cerenis TherapeuticsStephen Nicholls, MD PhD, Study chair, South Australian Health and Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484378
- Sponsor's protocol ID
- CER-001-CLIN-010
- Acronym
- CARAT
- Status last verified
- Jan 2017
- First submitted
- 25 Jun 2015
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: to be determined.
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-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.
PubMed 30046828
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02484378
- Acronym / sponsor ID
- CARAT / CER-001-CLIN-010
- Conditions
- Acute Coronary Syndromes
- Keywords
- ACS, IVUS, HDL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Cerenis Therapeutics, SAIndustry (pharma, biotech, devices)
- Collaborators
- South Australian Health and Medical Research Institute
- Study start
- Aug 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CER-001 | Experimental | Drug: CER-001CER-001 infusion |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CER-001Also: CAS 1383435-67-3Engineered pre-beta HDL particle | Drug | CER-001 |
| PlaceboAlso: Placebo for CER-001Normal saline | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Nominal Change in Normalized Total Atheroma Volume (TAV)
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Derived from this study: PubMed 30046828Nicholls 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.
- Individual participant dataSharing planned: Undecided. to be determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Keyserling, MS study director
Cerenis Therapeutics
Stephen Nicholls, MD PhD study chair
South Australian Health and Medical Research Institute
35 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CER-001 in people with Acute Coronary Syndromes, run by Cerenis Therapeutics, SA at 35 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Australia, Netherlands, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nominal Change in Percent Atheroma Volume (PAV) (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.