ANZCTR - Registration

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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]

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

Coronary artery disease

Condition category

Condition code

Cardiovascular

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]

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]

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]

Samples are drawn immediately pre-PCI, immediately post-PCI, 6 hours and 24hours post-PCI.

Primary outcome [2]

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]

Until discharge only

Secondary outcome [1]

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]

Samples are drawn immediately pre-PCI, immediately post-PCI, 6 hours and 24hours post-PCI.

Secondary outcome [2]

Microvascular function as assessed using index of microvascular resistance (IMR) derived from intracoronary pressure-wire during coronary angiography

Timepoint [2]

At the time of PCI.

Secondary outcome [3]

Atherosclerotic plaque vulnerability as assessed on Optical Coherence Tomography (OCT)

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [2]

Frankston Hospital - Frankston

Recruitment postcode(s) [1]

3065 - Fitzroy

Recruitment postcode(s) [2]

3199 - Frankston

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St. Vincent's Hospital Melbourne

Address [1]

41 Victoria Parade, Fitzroy 3065, Victoria

Country [1]

Australia

Primary sponsor type

Hospital

Name

St. Vincent's Hospital Melbourne

Address

41 Victoria Parade, Fitzroy 3065, Victoria

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Frankston Hospital

Address [1]

2 Hastings Road, Frankston 3199, Victoria

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St. Vincent's Health (Melbourne)

Ethics committee address [1]

41 Victoria Parade, Fitzroy 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/04/2015

Ethics approval number [1]

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

Dr Justin Cole

Address

59 Victoria Parade, Fitzroy 3065, Victoria

Country

Australia

Phone

+61 3 9288 4452

Fax

+61 3 8845 7073

[email protected]

Contact person for public queries

Name

Justin Cole

Address

59 Victoria Parade, Fitzroy 3065, Victoria

Country

Australia

Phone

+61 3 9288 4452

Fax

+61 3 8845 7073

[email protected]

Contact person for scientific queries

Name

Justin Cole

Address

59 Victoria Parade, Fitzroy 3065, Victoria

Country

Australia

Phone

+61 3 9288 4452

Fax

+61 3 8845 7073

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
5029	Ethical approval					368463-(Uploaded-23-09-2019-13-16-13)-Study-related document.pdf
5031	Study 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

Source	Title	Year of Publication	DOI
Embase	Colchicine to Prevent Periprocedural Myocardial Injury in Percutaneous Coronary Intervention: The COPE-PCI Pilot Trial.	2021	https://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009992
Embase	COlchicine to Prevent PeriprocEdural Myocardial Injury in Percutaneous Coronary Intervention (COPE-PCI): A Descriptive Cytokine Pilot Sub-Study.	2022	https://dx.doi.org/10.1016/j.carrev.2021.09.006
Embase	COlchicine to Prevent PeriprocEdural Myocardial Injury in Percutaneous Coronary Intervention (COPE-PCI): Coronary Microvascular Physiology Pilot Substudy.	2022	https://dx.doi.org/10.1155/2022/1098429

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically