Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001231134
Ethics application status
Approved
Date submitted
20/08/2019
Date registered
6/09/2019
Date last updated
6/09/2019
Date data sharing statement initially provided
6/09/2019
Date results information initially provided
6/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Colchicine on the release of Neutrophil Extra-cellular Traps after Percutaneous Coronary Intervention in Acute Coronary Syndrome Patients..
Scientific title
The effect of Colchicine on the release of Neutrophil Extra-cellular Traps after Percutaneous Coronary Intervention in Acute Coronary Syndrome Patients..
Secondary ID [1] 299075 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndrome 314104 0
Stable Angina Pectoris 314105 0
Condition category
Condition code
Cardiovascular 312480 312480 0 0
Coronary heart disease
Inflammatory and Immune System 312481 312481 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All colchicine administered was administered 6 to 24 hours prior to coronary angiography. This is due to uncertainty in waiting time for the angiogram depending on the angiogram list. Within this 6-24 hour window, the treatment group received TWO doses of colchicine. The first dose was a 1 mg oral tablet. After receiving this first dose, the second dose was a 0.5 mg oral tablet given 1 hour later. Hence all treatment group patients received 1.5mg of colchicine in total.

Colchicine was administered in alternating fashion, with every other patient receiving no colchicine.

All patients underwent coronary angiogram.
Intervention code [1] 315342 0
Treatment: Drugs
Comparator / control treatment
Control patient's were given no colchicine. There was no placebo pill.
Control group
Active

Outcomes
Primary outcome [1] 321122 0
Coronary Sinus Neutrophil Extracellular Traps (NETs) Area Under the Curve (AUC) measured using serum assays.
Timepoint [1] 321122 0
Calculated from five 45-second intervals peri-procedure.
Primary outcome [2] 321123 0
Coronary Sinus Human Neutrophil Elastase (HNE) AUC measured using serum assays.
Timepoint [2] 321123 0
Calculated from five 45-second intervals peri-procedure.
Primary outcome [3] 321124 0
Coronary Sinus Myeloperoxidase (MPO) AUC measured using serum assays.
Timepoint [3] 321124 0
Calculated from five 45-second intervals peri-procedure.
Secondary outcome [1] 374055 0
Change in peripheral NETs level measured using serum assays.
Timepoint [1] 374055 0
Within 24 hours (difference pre-and post procedure).

Pre-procedure is immediately before stent deployment
Post-procedure is 3 minutes post stent deployment
Secondary outcome [2] 374056 0
Change in peripheral HNE level measured using serum assays.
Timepoint [2] 374056 0
Within 24 hours (difference pre-and post procedure).

Pre-procedure is immediately before stent deployment
Post-procedure is 3 minutes post stent deployment
Secondary outcome [3] 374057 0
Change in peripheral MPO level measured using serum assays.
Timepoint [3] 374057 0
Within 24 hours (difference pre-and post procedure).

Pre-procedure is immediately before stent deployment
Post-procedure is 3 minutes post stent deployment
Secondary outcome [4] 374058 0
Change in peripheral high-sensitivity Troponin-T level measured using serum assays.
Timepoint [4] 374058 0
Within 24 hours (difference pre-and post procedure).

Pre-procedure is immediately before stent deployment
Post-procedure is 3 minutes post stent deployment

Eligibility
Key inclusion criteria
Patients with clinical indication for coronary angiogram and percutaneous coronary intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with >50% Left main artery stenosis
- Patients with cardiogenic shock
- Patients with haemodynamic instability
- Patients currently lactating
- Patients with known colchicine hypersensitivity
- Patients already taking colchicine before the procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/01/2016
Date of last participant enrolment
Anticipated
Actual
7/04/2017
Date of last data collection
Anticipated
Actual
7/04/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14601 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 27621 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 303609 0
Charities/Societies/Foundations
Name [1] 303609 0
Ramaciotti Health Investment Grant
Country [1] 303609 0
Australia
Primary sponsor type
Individual
Name
Sanjay Patel
Address
Department of Cardiology, Royal Prince Alfred Hospital, Missenden Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 303700 0
None
Name [1] 303700 0
None
Address [1] 303700 0
None
Country [1] 303700 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304137 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 304137 0
Level 11, KGV Building
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 304137 0
Australia
Date submitted for ethics approval [1] 304137 0
Approval date [1] 304137 0
09/08/2013
Ethics approval number [1] 304137 0
X12-0241 HREC/12/RPAH/377

Summary
Brief summary
Percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients is associated with a higher incidence of peri-procedural myocardial infarction. An increased release of neutrophil-derived inflammatory products is known to contribute to this process. Colchicine is a well-established anti-inflammatory drug, however its role in attenuating post-PCI release of activated neutrophil-mediators is not well known. This pilot study aims to investigate whether peri-procedural colchicine would suppress local release of Neutrophil Extracellular Traps, and its components Human Neutrophil Elastase and Myeloperoxidases, in both ACS and stable angina pectoris patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95934 0
Dr Kaivan Vaidya
Address 95934 0
Department of Cardiology,
Royal Prince Alfred Hospital
Missenden Road, Camperdown
NSW 2050
Country 95934 0
Australia
Phone 95934 0
+61295156111
Fax 95934 0
Email 95934 0
[email protected]
Contact person for public queries
Name 95935 0
Dr Kaivan Vaidya
Address 95935 0
Department of Cardiology,
Royal Prince Alfred Hospital
Missenden Road, Camperdown
NSW 2050
Country 95935 0
Australia
Phone 95935 0
+61295156111
Fax 95935 0
Email 95935 0
[email protected]
Contact person for scientific queries
Name 95936 0
Dr Kaivan Vaidya
Address 95936 0
Department of Cardiology,
Royal Prince Alfred Hospital
Missenden Road, Camperdown
NSW 2050
Country 95936 0
Australia
Phone 95936 0
+61295156111
Fax 95936 0
Email 95936 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


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
EmbaseColchicine inhibits neutrophil extracellular trap formation in patients with acute coronary syndrome after percutaneous coronary intervention.2021https://dx.doi.org/10.1161/JAHA.120.018993
N.B. These documents automatically identified may not have been verified by the study sponsor.