Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001437752
Ethics application status
Approved
Date submitted
22/08/2022
Date registered
9/11/2022
Date last updated
9/11/2022
Date data sharing statement initially provided
9/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Colchicine Atherosclerotic Plaque (CAP) – Biomarker and Imaging Sub-study (of the COLCARDIO-ACS and CASPER Studies)
Scientific title
Colchicine Atherosclerotic Plaque (CAP) – Biomarker and Imaging Sub-study
Secondary ID [1] 306269 0
Nil
Universal Trial Number (UTN)
Trial acronym
CAP
Linked study record
This record is a substudy to the following parent trials:
COLCARDIO-ACS Trial: ACTRN12616000400460
CASPER Trial: ACTRN12621001408875

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic inflammation 325020 0
Condition category
Condition code
Cardiovascular 322457 322457 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
36
Target follow-up type
Months
Description of intervention(s) / exposure
The following procedures will be performed in a sub-cohort of participants randomised to the COLCARDIO-ACS (ACTRN12616000400460) or CASPER (ACTRN12621001408875) Study:
- 18-F-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Imaging at Screening and 12 Months Follow Up. The procedure is anticipated to take up to 2 hours.
FDG will be administered intravenously by a nuclear medicine physician, and participants will be asked to sit or lie quietly for 60 mins for the FDG tracer to be absorbed.
- Computed Tomography Angiography (CTA) (Cardiac/ Aortic) Imaging at Screening and 12 Months Follow Up. The procedure is anticipated to take up to 20 minutes. Iodine-containing contrast medium (typically less than 100 mls) will be administered intravenously. This procedure will be conducted by either a nuclear medicine physician or a radiologist.
- Additional translational research blood collection at Screening, Randomisation, 12 Months Follow Up and End of Treatment.
Intervention code [1] 324793 0
Diagnosis / Prognosis
Comparator / control treatment
No control group. Imaging and translational research samples will be analysed by subgroups of parent trials (COLCARDIO-ACS [ACTRN12616000400460] or CASPER [ACTRN12621001408875]) treatment groups.
Control group
Active

Outcomes
Primary outcome [1] 330238 0
Change in ascending aorta tissue to background ratio (TBR) detected on 18FDG-PET/CT imaging
Timepoint [1] 330238 0
12 Months post-randomisation in parent trial (COLCARDIO-ACS [ACTRN12616000400460] or CASPER [ACTRN12621001408875])
Primary outcome [2] 330239 0
Change in carotid artery tissue to background ratio (TBR) detected on 18FDG-PET/CT imaging.
Timepoint [2] 330239 0
12 Months post-randomisation in parent trial (COLCARDIO-ACS [ACTRN12616000400460] or CASPER [ACTRN12621001408875])
Secondary outcome [1] 405391 0
Change in perivascular fat attenuation index (FAI) on CTA (Carotid/Aortic) imaging.
Timepoint [1] 405391 0
12 Months post-randomisation in parent trial (COLCARDIO-ACS [ACTRN12616000400460] or CASPER [ACTRN12621001408875])
Secondary outcome [2] 405392 0
Change in low attenuation plaque (LAP) volume on CTA (Carotid/Aortic) imaging
Timepoint [2] 405392 0
12 Months post-randomisation in parent trial (COLCARDIO-ACS [ACTRN12616000400460] or CASPER [ACTRN12621001408875])
Secondary outcome [3] 405393 0
Change in monocyte immunophenotyping (using whole blood)
Timepoint [3] 405393 0
12 Months post-randomisation in parent trial (COLCARDIO-ACS [ACTRN12616000400460] or CASPER [ACTRN12621001408875])

Eligibility
Key inclusion criteria
To be eligible participants must be:
1. Eligible for COLCARDIO-ACS (ACTRN12616000400460) or CASPER (ACTRN12621001408875) studies;
2. Aged 50 years or older
3. Willing and able to comply with sub-study visit schedule and nature of required assessments
4. Written informed consent
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who do not proceed to run-in for the COLCARDIO-ACS (ACTRN12616000400460) or CASPER (ACTRN12621001408875) studies will not be included.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Given an estimate of correlation between the primary outcomes of 0.75 (carotid artery TBR and ascending aorta TBR), this will allow the level of significance of each to be 3% to maintain an overall level of significance of 5%.
Assuming a baseline TBR of 2.43 and an SD of 0.5, and a conservative change from baseline of 0.3 (which corresponds to a 10% change) a total of 120 participants (60 per group) has 80% power, with significance level 0.03 and allowing for 10% dropouts.
In order to achieve a positive result, either of the primary outcomes can be <0.03.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/11/2022
Actual
Date of last participant enrolment
Anticipated
29/02/2024
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 23013 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 23014 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 38328 0
2050 - Camperdown
Recruitment postcode(s) [2] 38329 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 310620 0
Government body
Name [1] 310620 0
NSW Office for Health and Medical Research, Early-Mid Career Research Grant
Country [1] 310620 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
NHMRC Clinical Trials Centre
K25, Medical Foundation Building
Level 4-6, 92-94 Parramatta Road
Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 311828 0
None
Name [1] 311828 0
Address [1] 311828 0
Country [1] 311828 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310224 0
Sydney Local Health District (RPAH Zone) Human Research Ethics Committee
Ethics committee address [1] 310224 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 310224 0
Australia
Date submitted for ethics approval [1] 310224 0
01/02/2022
Approval date [1] 310224 0
15/08/2022
Ethics approval number [1] 310224 0
COLCARDIO - ETH2019/10246 (Form 73185)
Ethics committee name [2] 311913 0
Sydney Local Health District (RPAH Zone) Human Research Ethics Committee
Ethics committee address [2] 311913 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [2] 311913 0
Australia
Date submitted for ethics approval [2] 311913 0
01/02/2022
Approval date [2] 311913 0
15/08/2022
Ethics approval number [2] 311913 0
CASPER - ETH2021/11289 (Form 73193)

Summary
Brief summary
This imaging sub-study will use FDG-PET/CT & CTA angiography (Carotid/ Arotic) to answer the question of if Colchicine administration will reduce vascular inflammation and improve plaque stability.
Selected sites participating in the COLCARDIO-ACS (ACTRN12616000400460) and CASPER trials (ACTRN12621001408875) trials will be participating in this CAP sub-study. A sub-set of these sites will collect additional research blood for 40 participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116910 0
Prof Sanjay Patel
Address 116910 0
NHMRC Clinical Trials Centre
92-94 Parramatta Road
Camperdown NSW 2050
Country 116910 0
Australia
Phone 116910 0
+61 2 9562 5000
Fax 116910 0
Email 116910 0
sanjay.patel@sydney.edu.au
Contact person for public queries
Name 116911 0
Miss Jessie Payne
Address 116911 0
NHMRC Clinical Trials Centre
92-94 Parramatta Road
Camperdown NSW 2050
Country 116911 0
Australia
Phone 116911 0
+61 2 95625017
Fax 116911 0
Email 116911 0
jessie.payne@sydney.edu.au
Contact person for scientific queries
Name 116912 0
A/Prof Sanjay Patel
Address 116912 0
NHMRC Clinical Trials Centre
92-94 Parramatta Road
Camperdown NSW 2050
Country 116912 0
Australia
Phone 116912 0
+61 2 9562 5000
Fax 116912 0
Email 116912 0
sanjay.patel@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.