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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02484378




Registration number
NCT02484378
Ethics application status
Date submitted
25/06/2015
Date registered
29/06/2015
Date last updated
11/02/2019

Titles & IDs
Public title
CER-001 Atherosclerosis Regression ACS Trial
Scientific 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
Secondary ID [1] 0 0
CER-001-CLIN-010
Universal Trial Number (UTN)
Trial acronym
CARAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndromes 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CER-001
Treatment: Drugs - Placebo

Experimental: CER-001 - CER-001 infusion

Placebo Comparator: Placebo - Placebo infusion


Treatment: Drugs: CER-001
Engineered pre-beta HDL particle

Treatment: Drugs: Placebo
Normal saline
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Nominal Change in Percent Atheroma Volume (PAV)
Timepoint [1] 0 0
Baseline to 12 weeks
Secondary outcome [1] 0 0
Nominal Change in Normalized Total Atheroma Volume (TAV)
Timepoint [1] 0 0
Baseline to 12 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
301
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford park
Recruitment hospital [5] 0 0
Queen Elizabeth Hospital - Woodville South
Recruitment hospital [6] 0 0
Peninsula Heart Centre - Frankston
Recruitment hospital [7] 0 0
Epworth Research Institute - Richmond
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5042 - Bedford park
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3121 - Richmond
Recruitment postcode(s) [8] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Hungary
State/province [12] 0 0
Budapest
Country [13] 0 0
Hungary
State/province [13] 0 0
Debrecen
Country [14] 0 0
Hungary
State/province [14] 0 0
Gyula
Country [15] 0 0
Hungary
State/province [15] 0 0
Kecskemet
Country [16] 0 0
Hungary
State/province [16] 0 0
Szeged
Country [17] 0 0
Netherlands
State/province [17] 0 0
Amersfoort
Country [18] 0 0
Netherlands
State/province [18] 0 0
Amsterdam
Country [19] 0 0
Netherlands
State/province [19] 0 0
Emmen
Country [20] 0 0
Netherlands
State/province [20] 0 0
Leidschendam
Country [21] 0 0
Netherlands
State/province [21] 0 0
Nijmegen
Country [22] 0 0
Netherlands
State/province [22] 0 0
Rotterdam
Country [23] 0 0
Netherlands
State/province [23] 0 0
Tilburg
Country [24] 0 0
Netherlands
State/province [24] 0 0
Venlo

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cerenis Therapeutics, SA
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
South Australian Health and Medical Research Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02484378
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Connie Keyserling, MS
Address 0 0
Cerenis Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02484378