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Trial registered on ANZCTR


Registration number
ACTRN12615001194550
Ethics application status
Approved
Date submitted
23/10/2015
Date registered
4/11/2015
Date last updated
4/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Low dose Colchicine after Acute Myocardial Infarction: LoDoCo-MI
Scientific title
Low dose colchicine in survivors of an acute myocardial infarction: A pilot randomised clinical trial to establish feasibility and safety and to assess the effects on levels of inflammatory markers.
Secondary ID [1] 287441 0
Nil
Universal Trial Number (UTN)
Trial acronym
LoDoCo-MI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction (type 1 using the 3rd universal definition) 296155 0
Cardiovascular disease 296157 0
Condition category
Condition code
Cardiovascular 296441 296441 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Colchicine o.5mg once daily, oral tablet for 30 days following enrolment.
Adherence will be assessed by counting returned tablets.
Intervention code [1] 292811 0
Treatment: Drugs
Intervention code [2] 293112 0
Prevention
Comparator / control treatment
Placebo (lactose, maize starch, povidone, magnesium strearate)

Control group
Placebo

Outcomes
Primary outcome [1] 296059 0
The primary end point is the proportion of patients with CRP levels in blood > or equal to 2mg/L at 30 days in the active treatment v the control group
Timepoint [1] 296059 0
30 days after commencing study treatment (treatment will be started within 7 days of the index myocardial infarction).
Secondary outcome [1] 317400 0
actual blood levels of CRP at 30 days
Timepoint [1] 317400 0
30 days after commencing study treatment
Secondary outcome [2] 318531 0
relative and absolute change in CRP levels from baseline will be assessed by blood sample.
Timepoint [2] 318531 0
30 days after commencing study treatment
Secondary outcome [3] 318532 0
compliance assessed by information from the participant and pill count with return of drug bottles.
Timepoint [3] 318532 0
30 days after commencing study treatment
Secondary outcome [4] 318533 0
blood neutrophil count, via blood samples
Timepoint [4] 318533 0
30 days after commencing study treatment
Secondary outcome [5] 318534 0
blood creatinine kinase levels by blood samples
Timepoint [5] 318534 0
30 days after commencing study treatment
Secondary outcome [6] 318535 0
death and major cardiovascular events (myocardial infarction or stroke), via telephone contact with Next of Kin and hospital records.
Timepoint [6] 318535 0
30 days after commencing study treatment
Secondary outcome [7] 318613 0
Adverse Events (such as gastrointestinal upset or less commonly, myotoxicity) will be assessed by direct information from the participant and a 'study acceptability questionnaire' and/or medical records.
Timepoint [7] 318613 0
30 days after commencing study treatment.

Eligibility
Key inclusion criteria
Patients with a type 1 myocardial infarction within the prior 7 days
Age > 18 years.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of myopathy, leukopenia or thrombocytopenia.
eGFR <45ml/min per 1.73m2.
Severe hepatic dysfunction (alanine aminotransferase >3 x ULN).
therapy with a p-glycoprotein inhibitor (e.g. cyclosporine, verapamil or quinidine) or a strong CYP3A4 inibitor (e.g. ritonavir, clarithromycin or ketoconazole).
Pregnancy, lactation or women of childbearing age, not using contraception.
An indication for colchicine therapy.

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)
Patients will be recruited following diagnosis of an acute MI (myocardial infarction). Randomisation and allocation of the study treatment with be done with the cooperation of the clinical trials pharmacy at Royal Perth Hospital. The study treatment is dispensed from the clinical trials pharmacy in identical bottles (therefore research staff and patients are blinded to the treatment allocation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Daily review of all potential in-patients will occur and they will be reviewed as an 'all comers' basis. Once they agree to participate in the study, with signed conent, the study script is sent to the pharmacy to allocate and dispense the study medication.
Permuted block randomisation will be used.
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 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
A study of 210 patients will have a 90% power (2 sided alpha=0.05) to detect a 50% reduction in the prevelance of CRP levels above this threshold (i.e. to 21% with CRP > or equal to 2mg/L) allowing for 7% data loss.

Recruitment
Recruitment status
Not yet 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)
WA
Recruitment hospital [1] 4330 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 10475 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 292017 0
Charities/Societies/Foundations
Name [1] 292017 0
Heart Foundation
Address [1] 292017 0
Level 12, 500 Collins Street Melbourne VICTORIA 3000
Country [1] 292017 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
197 Wellington Street, Perth, WA 6000
Country
Australia
Secondary sponsor category [1] 290945 0
University
Name [1] 290945 0
University of Western Australia
Address [1] 290945 0
35 Stirling Highway, Crawley, Perth WA 6009
Country [1] 290945 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293742 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 293742 0
Royal Perth Hospital, 197 Wellington Street, Perth WA 6000
Ethics committee country [1] 293742 0
Australia
Date submitted for ethics approval [1] 293742 0
Approval date [1] 293742 0
11/09/2015
Ethics approval number [1] 293742 0
15-090

Summary
Brief summary
This randomised placebo-controlled trial will recruit 210 patients following an acute myocardial infarction (MI). They will be randomised to colchicine 0.5mg once daily or matching placebo for 30-days. Patients, health-care providers, data collectors and outcome adjudicators will be blinded to treatment allocation. Randomisation will occur within 7 days of the index MI and will be stratified by study centre. Baseline clinical data, including concomitant medications, serum biochemistry, full blood count and creatine kinase will be recorded. These blood tests will be repeated at 30 days. Levels of C-reactive protein (CRP) will also be measured at baseline and at 30-days.

Patients with a type 1 MI (using the 3rd universal definition) will be eligible for inclusion unless they have a know contraindication to, intolerance of or clear indication for treatment with colchicine. The primary aims of this study are to provide data regarding the feasibility, tolerability and safety of low-dose colchicine after acute MI. The secondary end-points relate to the ability of colchicine to reduce CRP. Data from this trial will be used to inform the design of a larger outcome trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60182 0
Prof Graham Hillis
Address 60182 0
Department of Cardiology, Royal Perth Hospital, 197 Wellington Street, Perth, Western Australia 6000
Country 60182 0
Australia
Phone 60182 0
+ 61 8 9224 3180
Fax 60182 0
Email 60182 0
graham.hillis@health.wa.gov.au
Contact person for public queries
Name 60183 0
Mrs Michelle Bonner
Address 60183 0
Department of Cardiology, Royal Perth Hospital, 197 Wellington Street, Perth, Western Australia 6000
Country 60183 0
Australia
Phone 60183 0
+ 61 8 9224 8069
Fax 60183 0
Email 60183 0
michelle.bonner@health.wa.gov.au
Contact person for scientific queries
Name 60184 0
Prof Graham Hillis
Address 60184 0
Department of Cardiology, Royal Perth Hospital, 197 Wellington Street, Perth, Western Australia 6000
Country 60184 0
Australia
Phone 60184 0
+61 8 9224 3180
Fax 60184 0
Email 60184 0
graham.hillis@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results