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Trial registered on ANZCTR


Registration number
ACTRN12610000293066
Ethics application status
Approved
Date submitted
8/04/2010
Date registered
13/04/2010
Date last updated
18/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The LoDoCo Trial: The effect of low dose colchicine on the natural history of patients with stable coronary artery disease
Scientific title
The LoDoCo Trial: The effect of low dose colchicine on the natural history of patients with stable coronary artery disease
Secondary ID [1] 1589 0
Nil
Universal Trial Number (UTN)
U1111-1114-5895
Trial acronym
LoDoCo Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 257060 0
Acute ischemic coronary events 257061 0
Acute ischemic cerebrovascular events 257062 0
Condition category
Condition code
Cardiovascular 257217 257217 0 0
Coronary heart disease
Stroke 257273 257273 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Colchicine 0.5mg/day orally for duration of study period unless side effects occur [minimum of 2 years]
Intervention code [1] 256230 0
Treatment: Drugs
Comparator / control treatment
No colchicine
Control group
Active

Outcomes
Primary outcome [1] 258109 0
Composite of: Major Adverse Cardiac or Cerebrovascular Events [MACCE] including [a] Acute coronary sydromes as evidenced by a history of ischemic chest pain, changes in the electrocardiogram and a rise in serum Troponin above the normal range [b] Unstable [new or worsening] angina associated with a documented change in coronary anatomy as evidenced by repeat angiography [c] Sudden Cardiac Death as evidenced by the death certificate or non-fatal out of hospital cardiac arrest [d] New [documented] stroke unrelated to atrial fibrillation or intra-cranial hemorrhage as evidenced by a diagnostic change on cerebral tomography [CT] or magnetic resonant imaging [MRI] of the brain AND after review of the patient and all relevant data by an independent specialist neurologist]
Timepoint [1] 258109 0
The final analysis will occur once the last patient enrolled to the study has been followed for 2 years.
Secondary outcome [1] 263727 0
Tolerability to therapy as evidenced by the patients self reporting of side-effects and willingness to continue therapy.
Timepoint [1] 263727 0
Intolerance will be considered as being 'early' if the patient chooses to cease treatment due to percieved side effect within 1 month of starting treatment, and 'late' if side-effects begin after that time

Eligibility
Key inclusion criteria
Angiographic proof of coronary disease
Clinically stable for >6months
Coronary Artery Bypass Grafting [CABG] more than 10 years ago or CABG at any time if the patient had subesquently had recurrent angina and angiographic evidence of blocked grafts or progressive native coronary disease requiring intervention with angioplasty
Willing to be randomised
Likely to be compliant
Minimum age
35 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any clinically significant co-morbidity
Clinical instability within prior 6 months CABG<10 years ago unless intervention has been required
Unwilling to enrole or uncertainty re compliance
Already on long-term colchicine for unrelated condition
Known sensitivity to colchicine
Pregnancy

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 attending out-patient cardiology clinic are told about the study and asked to enter the trial. If they agree the patients information and signed consent form are forwarded to an independent person who then enters the patients clinical details into the study data bases in a sequential manner.

The first column of the data base has a random seqence of '1' or '0' indicating whether the patient will [1] or will not [0] recience therapy.

Hence the treating Cardiologist is blinded to the randomisation sequence at the time the patient is recruited into the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization sequence was generated by computer and held by an independent 3rd party and remained concealed form the referring Cardiologists
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Additional patients will be randomized to replace patients who cease the study drug within 30 days because of intolerance to treatment
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 256730 0
Self funded/Unfunded
Name [1] 256730 0
Mark Nidorf
Address [1] 256730 0
3/140 Mounts Bay Rd
Perth 6000
Western Australia
Country [1] 256730 0
Australia
Funding source category [2] 285226 0
Other
Name [2] 285226 0
Heart Care Western Australia.
Address [2] 285226 0
3/140 Mounts Bat Rd
Perth
Western Australia
Country [2] 285226 0
Australia
Funding source category [3] 285227 0
Hospital
Name [3] 285227 0
Heart Research Institute of Western Australia
Address [3] 285227 0
Sir Charles Gairdner Hospital
Verdun St
Nedlands
Country [3] 285227 0
Australia
Primary sponsor type
Individual
Name
Mark Nidorf
Address
3/140 Mounts Bay Rd
Perth 6000
Western Australia
Country
Australia
Secondary sponsor category [1] 256018 0
Hospital
Name [1] 256018 0
Heart Research Institute of Western Australia
Address [1] 256018 0
Queen Elizabeth II Hospital
Nedlands
Perth 6009
Western Australia
Country [1] 256018 0
Australia
Secondary sponsor category [2] 256023 0
Individual
Name [2] 256023 0
John Eikelboom
Address [2] 256023 0
Henderson Reseach Centre
McMaster University
711 Concession Street
Hamilton, Ontario
Canada
L8V 1C3
Country [2] 256023 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258762 0
Queen Elizabeth II Hospital
Ethics committee address [1] 258762 0
Verdun St
Nedlands, 6009
Perth
Western Australia
Ethics committee country [1] 258762 0
Australia
Date submitted for ethics approval [1] 258762 0
01/02/2008
Approval date [1] 258762 0
01/07/2008
Ethics approval number [1] 258762 0
2008-001

Summary
Brief summary
Prospective Randomized Observer Blinded Evaluation trial to determine the effect of adding colchicine 0.5mg/d to usual medical therapy in patients with proven coronary disease on the risk of future coronary events and stroke [unrelated to atrial fibrillation or intra-cranial hemorrhage]
Trial website
N/A
Trial related presentations / publications
Presented AHA November 2012

Published
Nidorf SM, Eikelboom JW, Budgeon CA, Thompson PL. Low-Dose Colchicine for Secondary Prevention of Cardiovascular Disease. J Am Coll Cardiol.
2012 Dec 13. SO735-1097(12)05478-2. JACC Jan 13
Public notes

Contacts
Principal investigator
Name 30997 0
Dr Mark Nidorf
Address 30997 0
Heart Care Western Australia
3/140 Mounts Bay Rd
Perth 6000
Western Australia
Country 30997 0
Australia
Phone 30997 0
+61413145410
Fax 30997 0
+61 8 93211012
Email 30997 0
smnidorf@gmail.com
Contact person for public queries
Name 14244 0
Dr Mark Nidorf
Address 14244 0
3/140 Mounts Bay Rd
Perth 6000
Western Australia
Country 14244 0
Australia
Phone 14244 0
+61413145410
Fax 14244 0
+61 8 93211012
Email 14244 0
smnidorf@gmail.com
Contact person for scientific queries
Name 5172 0
Dr Mark Nidorf
Address 5172 0
3/140 Mounts Bay Rd
Perth 6000
Western Australia
Country 5172 0
Australia
Phone 5172 0
+61413145410
Fax 5172 0
+61 8 93211012
Email 5172 0
smnidorf@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary