Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000809235
Ethics application status
Approved
Date submitted
13/04/2018
Date registered
11/05/2018
Date last updated
3/05/2023
Date data sharing statement initially provided
1/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
COCOMO-ACS Study: The Colchicine for coronary plaque modification in Acute Coronary Syndrome Study
Scientific title
The Colchicine for coronary plaque modification in Acute Coronary Syndrome study
Secondary ID [1] 292656 0
Nil known
Universal Trial Number (UTN)
U1111-1200-7393
Trial acronym
COCOMO-ACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 304391 0
Coronary Artery Disease 304392 0
Non-ST elevation myocardial infarction 304393 0
Condition category
Condition code
Cardiovascular 303724 303724 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomly assigned to treatment or control group for 12 months.

Treatment group will be given Colchicine 0.5mg once a day orally for 12 months.

Control group will be given placebo tablet to take once a day for 12 months.

Participants will return all bottles (empty and partially used) to monitor adherence.
Intervention code [1] 298890 0
Treatment: Drugs
Comparator / control treatment
Placebo is a microcellulose tablet matched to the colchicine tablet
Control group
Placebo

Outcomes
Primary outcome [1] 303097 0
To compare the percentage change in coronary plaque minimum fibrous cap thickness (FCT) as determined by OCT.
Timepoint [1] 303097 0
12 months
Secondary outcome [1] 337879 0
To compare the absolute change in plaque minimum FCT as determined by OCT.
Timepoint [1] 337879 0
12 months
Secondary outcome [2] 337880 0
To compare the absolute and percentage change in plaque mean FCT as determined by OCT.
Timepoint [2] 337880 0
12 months
Secondary outcome [3] 340763 0
To compare the change in plaque lipid pool size, as determined by OCT measurements of lipid arc and length
Timepoint [3] 340763 0
12 months
Secondary outcome [4] 340764 0
To compare the change in plaque macrophage content as determined by OCT.
Timepoint [4] 340764 0
12 months

Eligibility
Key inclusion criteria
1. Participants who undergo clinically indicated coronary angiography within 72 hours of presenting with NSTEMI.
2. Participants able to provide written informed consent before baseline angiography.
3. Male or female >= 18 and <=82 years of age at screening.
4. Participants must meet all of the following criteria at the qualifying coronary catheterisation procedure:
a. Angiographic evidence of coronary artery disease, with a culprit lesion identifiable
for the NSTEMI, and managed as clinically indicated
b. Target coronary artery for OCT:
i. At least one non-culprit intermediate lesion in a non-culprit
artery, determined angiographically to be 20-50% stenotic.
ii. When multiple non-culprit intermediate lesions are present, the most
angiographically severe one will be imaged.
iii. Vessel for interrogation must be accessible to the OCT catheter.
iv. Target vessel has not undergone prior percutaneous coronary intervention
(PCI) or coronary artery bypass graft (CABG) surgery, and is not a bypass
graft.
v. Target vessel is not currently a candidate for intervention or a likely
candidate for intervention over the next 12 months.
5. Participants able to be randomised within seven days of catheterisation..
6. Baseline OCT interrogation determined to be of acceptable quality, and contain a lipid-rich plaque with a FCT <=120µm and lipid arc >=90° , at review by the Atherosclerosis Imaging Core Laboratory at SAHMRI.
Minimum age
18 Years
Maximum age
82 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Left main coronary disease (>50% reduction in lumen diameter by angiographic visual estimation).
2. Cardiogenic shock.
3. Heart failure (New York Heart Association (NYHA) class IV) or LVEF <= 35%.
4. Participants with known gout within the last 5 years.
5. Currently prescribed colchicine for other indication, presence of contraindications to colchicine, or known prior intolerance to colchicine. Concomitant therapy with drugs that could interact with colchicine (eg strong CYP3A4)
6. Dialysis or estimated glomerular infiltration rate (eGFR) < 30 ml/min/1.73m²
7. Thyroid stimulating hormone (TSH) < lower limit of normal (LLN) or >1.5x upper limit of normal (ULN)
8. Active liver disease or hepatic dysfunction, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the ULN as determined by analysis at screening
9. Known major active infection, or major haematologic, renal, metabolic, gastrointestinal or endocrine dysfunction
10. Significant haematological abnormalities on assessment of complete blood picture: Hb <100 g/L, Plt <150x103 /µL, white cell count < 3.5x103 /µL.
11. History or malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or stage 1 prostate carcinoma).
12. Female patients cannot be pregnant or breast feeding and premenopausal patients must be willing to use at least 1 highly effective method of birth control during treatment and for an additional 12 weeks after the end of treatment.
13. Unable to give informed consent.
14. Not willing or able to attend follow up visits or follow up OCT procedure at 12 months.
15. Any other information that the investigator considers will limit the ability of the patient to complete all study associated procedures

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)
Randomisation via a web based randomisation system
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
Efficacy
Statistical methods / analysis
Intention-to-treat analysis will be the primary analysis. Descriptive statistics will be presented as percentage frequencies for categorical variables and as mean±SD (or as median with interquartile range) for continuous variables by treatment group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/09/2018
Actual
24/12/2018
Date of last participant enrolment
Anticipated
1/06/2020
Actual
31/03/2021
Date of last data collection
Anticipated
1/08/2022
Actual
18/10/2022
Sample size
Target
64
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 9207 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 13023 0
Gold Coast University Hospital - Southport
Recruitment hospital [3] 13024 0
The Northern Hospital - Epping
Recruitment hospital [4] 13025 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 14623 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [6] 15020 0
Royal Perth Hospital - Perth
Recruitment hospital [7] 19823 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [8] 19824 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [9] 19825 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 17862 0
5000 - Adelaide
Recruitment postcode(s) [2] 25509 0
4215 - Southport
Recruitment postcode(s) [3] 25510 0
3076 - Epping
Recruitment postcode(s) [4] 25511 0
5042 - Bedford Park
Recruitment postcode(s) [5] 27647 0
3168 - Clayton
Recruitment postcode(s) [6] 28307 0
6000 - Perth
Recruitment postcode(s) [7] 34511 0
5112 - Elizabeth Vale
Recruitment postcode(s) [8] 34512 0
2050 - Camperdown
Recruitment postcode(s) [9] 34513 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 297290 0
Government body
Name [1] 297290 0
NHMRC
Country [1] 297290 0
Australia
Funding source category [2] 298061 0
Charities/Societies/Foundations
Name [2] 298061 0
Heart Foundation
Country [2] 298061 0
Australia
Primary sponsor type
Other
Name
South Australian Health and Medical Research Insititute
Address
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 297136 0
None
Name [1] 297136 0
Address [1] 297136 0
Country [1] 297136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298400 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 298400 0
Ethics committee country [1] 298400 0
Australia
Date submitted for ethics approval [1] 298400 0
04/09/2017
Approval date [1] 298400 0
21/11/2017
Ethics approval number [1] 298400 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76962 0
Dr Peter Psaltis
Address 76962 0
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace
Adelaide SA 5000
Country 76962 0
Australia
Phone 76962 0
+61 8 8128 4534
Fax 76962 0
Email 76962 0
[email protected]
Contact person for public queries
Name 76963 0
Peter Psaltis
Address 76963 0
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace
Adelaide SA 5000
Country 76963 0
Australia
Phone 76963 0
+61 8 8128 4534
Fax 76963 0
Email 76963 0
[email protected]
Contact person for scientific queries
Name 76964 0
Peter Psaltis
Address 76964 0
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace
Adelaide SA 5000
Country 76964 0
Australia
Phone 76964 0
+61 8 8128 4534
Fax 76964 0
Email 76964 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
there is currently no plan to make individual participant data (IPD) publicly available for this trial


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe role of intracoronary imaging in translational research2020https://doi.org/10.21037/cdt-20-1
EmbaseAssessing the Impact of Colchicine on Coronary Plaque Phenotype After Myocardial Infarction with Optical Coherence Tomography: Rationale and Design of the COCOMO-ACS Study.2022https://dx.doi.org/10.1007/s10557-021-07240-9
EmbaseInflammation in Coronary Atherosclerosis and Its Therapeutic Implications.2022https://dx.doi.org/10.1007/s10557-020-07106-6
N.B. These documents automatically identified may not have been verified by the study sponsor.