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Trial registered on ANZCTR


Registration number
ACTRN12615000485538
Ethics application status
Approved
Date submitted
4/05/2015
Date registered
15/05/2015
Date last updated
18/02/2021
Date data sharing statement initially provided
24/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
COlchicine to Prevent PeriprocEdural myocardial injury in Percutaneous Coronary Intervention (COPE-PCI Trial)
Scientific title
Physiology of Acute Coronary Syndromes: Focus On microvascular dysfunction and inflammation
Secondary ID [1] 286625 0
Nil
Universal Trial Number (UTN)
U1111-1169-8018
Trial acronym
COPE-PCI Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndromes 294944 0
Coronary artery disease 295009 0
Condition category
Condition code
Cardiovascular 295201 295201 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be receiving a STAT oral dose of colchicine 6 to 24 hours prior to the percutaneous coronary intervention procedure. The STAT dose is given as 1mg followed 1 hour later by 0.5mg of colchicine: Three tablets in total.
Intervention code [1] 291760 0
Treatment: Drugs
Comparator / control treatment
Standard medical therapy as per current acute coronary syndrome management guidelines which includes dual antiplatelet therapy, statin, beta blocker and angiotensin converting enzyme (ACE) inhibitor.
Control group
Active

Outcomes
Primary outcome [1] 294956 0
Periprocedural myocardial infarction as assessed using biochemical tests (troponin and CKMB) on patient serum samples. These cardiac enzymes will be measured in samples drawn immediately pre-PCI, immediately post-PCI, 6 hours and 24hours post-PCI.
Timepoint [1] 294956 0
Samples are drawn immediately pre-PCI, immediately post-PCI, 6 hours and 24hours post-PCI.
Primary outcome [2] 294957 0
Major adverse cardiovascular events: cardiovascular death, fatal or non-fatal myocardial infarction, urgent revascularization, and non-cardioembolic ischaemic stroke. The information will be gathered from interviews and/or patient medical records.
Timepoint [2] 294957 0
Until discharge only
Secondary outcome [1] 314467 0
Inflammatory markers (such as CRP, soluble RAGE, IL6 (and other cytokines) and CD40 ligand) as assessed using biochemical tests on patient serum samples.
Timepoint [1] 314467 0
Samples are drawn immediately pre-PCI, immediately post-PCI, 6 hours and 24hours post-PCI.
Secondary outcome [2] 314479 0
Microvascular function as assessed using index of microvascular resistance (IMR) derived from intracoronary pressure-wire during coronary angiography
Timepoint [2] 314479 0
At the time of PCI.
Secondary outcome [3] 392051 0
Atherosclerotic plaque vulnerability as assessed on Optical Coherence Tomography (OCT)
Timepoint [3] 392051 0
At the time of PCI

Eligibility
Key inclusion criteria
Patients admitted with acute coronary syndromes
Multivessel disease on coronary angiography with plan for staged PCI
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe hepatic and renal impairment
Patients who are intolerant of colchicine
Pre-existing colchicine use for other medical conditions
Concurrent administration of immunosuppressant therapy
Known active malignancy
Pregnancy or lactating women

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)
All ACS patients who are admitted to the hospital will be screened for eligibility. Randomisation to colchicine therapy will occur prior to the coronary angiography/angioplasty. Patients are randomised to drug A or drug B.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis
Continuous variables will be summarized by means, standard deviations, medians and ranges. Categorical variables will be summarized by frequencies and percentages.

In order to assess comparability of treatment groups, subject demographics and other baseline characteristics will be tabulated separately by treatment group.

This is a proof-of-concept study designed to test the feasibility and safety of such intervention in ACS populations. The study is not designed to test the superiority of one treatment over the other. We anticipate to recruit 50 patients over a period of 12 months. If proven feasible and safe, a larger randomised controlled trial can be conducted to assess the efficacy of colchicine therapy in ACS.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/05/2015
Actual
3/07/2017
Date of last participant enrolment
Anticipated
30/12/2019
Actual
29/12/2019
Date of last data collection
Anticipated
Actual
30/12/2019
Sample size
Target
75
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3739 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 3740 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 9622 0
3065 - Fitzroy
Recruitment postcode(s) [2] 9623 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 291195 0
Hospital
Name [1] 291195 0
St. Vincent's Hospital Melbourne
Country [1] 291195 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital Melbourne
Address
41 Victoria Parade, Fitzroy 3065, Victoria
Country
Australia
Secondary sponsor category [1] 289874 0
Hospital
Name [1] 289874 0
Frankston Hospital
Address [1] 289874 0
2 Hastings Road, Frankston 3199, Victoria
Country [1] 289874 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292766 0
St. Vincent's Health (Melbourne)
Ethics committee address [1] 292766 0
41 Victoria Parade, Fitzroy 3065
Ethics committee country [1] 292766 0
Australia
Date submitted for ethics approval [1] 292766 0
Approval date [1] 292766 0
15/04/2015
Ethics approval number [1] 292766 0
HREC-A 010/10

Summary
Brief summary
This study aims (1) to define the atherosclerotic plaque characteristics, inflammation and microvascular physiology in patients with acute coronary syndromes; (2) to evaluate the impacts of colchicine on atherosclerotic plaques, inflammation and microvascular physiology in ACS; and (3) to correlate plaque morphology and coronary physiology with future cardiac events
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56910 0
Dr Justin Cole
Address 56910 0
59 Victoria Parade, Fitzroy 3065, Victoria
Country 56910 0
Australia
Phone 56910 0
+61 3 9288 4452
Fax 56910 0
+61 3 8845 7073
Email 56910 0
[email protected]
Contact person for public queries
Name 56911 0
Justin Cole
Address 56911 0
59 Victoria Parade, Fitzroy 3065, Victoria
Country 56911 0
Australia
Phone 56911 0
+61 3 9288 4452
Fax 56911 0
+61 3 8845 7073
Email 56911 0
[email protected]
Contact person for scientific queries
Name 56912 0
Justin Cole
Address 56912 0
59 Victoria Parade, Fitzroy 3065, Victoria
Country 56912 0
Australia
Phone 56912 0
+61 3 9288 4452
Fax 56912 0
+61 3 8845 7073
Email 56912 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
Confidential and identifiable information will not be made publicly available.
No individual participant data will be made public.
This change was made prior to recruitment commencement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5029Ethical approval    368463-(Uploaded-23-09-2019-13-16-13)-Study-related document.pdf
5031Study protocol    368463-(Uploaded-23-09-2019-13-23-50)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseColchicine to Prevent Periprocedural Myocardial Injury in Percutaneous Coronary Intervention: The COPE-PCI Pilot Trial.2021https://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009992
EmbaseCOlchicine to Prevent PeriprocEdural Myocardial Injury in Percutaneous Coronary Intervention (COPE-PCI): A Descriptive Cytokine Pilot Sub-Study.2022https://dx.doi.org/10.1016/j.carrev.2021.09.006
EmbaseCOlchicine to Prevent PeriprocEdural Myocardial Injury in Percutaneous Coronary Intervention (COPE-PCI): Coronary Microvascular Physiology Pilot Substudy.2022https://dx.doi.org/10.1155/2022/1098429
N.B. These documents automatically identified may not have been verified by the study sponsor.