The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000809235
Ethics application status
Approved
Date submitted
13/04/2018
Date registered
11/05/2018
Date last updated
1/02/2019
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
Lactose (SuperTab), maize starch, povidone K-29/32, magnesium stearate BP (veg)
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° , for three consecutive frames, at review by the Atherosclerosis Imaging Core Laboratory at SAHMRI.
Minimum age
18 Years
Maximum age
82 Years
Gender
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.
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, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times the ULN as determined by analysis at screening
9. Previous diagnosis of Vitamin B12 deficiency, or current blood level of active Vitamin B12 that is below the normal range.
10. Known major active infection, or major haematologic, renal, metabolic, gastrointestinal or endocrine dysfunction
11. Significant haematological abnormalities on assessment of complete blood picture: Hb <100 g/L, Plt <150x103 /µL, white cell count < 3.5x103 /µL.
12. History or malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or stage 1 prostate carcinoma).
13. 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.
14. Unable to give informed consent.
15. Not willing or able to attend follow up visits or follow up OCT procedure at 12 months.
16. 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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 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

Funding & Sponsors
Funding source category [1] 297290 0
Government body
Name [1] 297290 0
NHMRC
Address [1] 297290 0
Research Committee Secretariat
NHMRC
GPO Box 1421
Canberra ACT 2601
Country [1] 297290 0
Australia
Funding source category [2] 298061 0
Charities/Societies/Foundations
Name [2] 298061 0
Heart Foundation
Address [2] 298061 0
Unit 1, Level 1, 17-23 Townshend Street
Phillip ACT 2606
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
Port Road
Adelaide SA 5000
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
This research study aims to recruit 82 patients following an admission for chest pain or heart attack. The patients will be randomised to Colchicine 0.5mg daily or placebo for 12 months. This study aims to see how Colchicine acts on the coronary plaque. This medication is currently used for inflammatory conditions such as gout. It has a broad anti-inflammatory effect and previous research has shown that Colchicine helps to reduce adverse cardiovascular events in patients with coronary artery disease.
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
peter.psaltis@sahmri.com
Contact person for public queries
Name 76963 0
Dr 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
peter.psaltis@sahmri.com
Contact person for scientific queries
Name 76964 0
Dr 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
peter.psaltis@sahmri.com

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 other documents available
Summary results
Not applicable