Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000397011
Ethics application status
Approved
Date submitted
29/04/2010
Date registered
18/05/2010
Date last updated
18/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
LoDoCo - VRIC Low Dose Colchicine in stable coronary artery disease, Vascular Reactivity and the Inflammatory Cascade.
Scientific title
The effect of low dose colchicine(1mg/dy) administered to patients with stable coronary artery disease compared with no treatment on brachial artery flow mediated dilation and blood inflammatory markers.
Secondary ID [1] 251666 0
nil
Universal Trial Number (UTN)
Trial acronym
LoDoCo-VRIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 257265 0
Condition category
Condition code
Cardiovascular 257405 257405 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are randomly assigned to treatment or control group initially and then cross over to the alternate group after a one month washout period.

Colchicine 1mg/day oral tablets for three months on top of standard medical therapy will be administered while in the treatment group.

Standard medical therapy will include any of the following and is at the discretion of the primary care physician: Statins, Angiotensin Converting Enzyme inhibitors, Beta Blockers and Aspirin.

Flow mediated dilation testing is performed at baseline and after three months participation in both control and treatment arms.
Intervention code [1] 256383 0
Treatment: Drugs
Intervention code [2] 256497 0
Prevention
Comparator / control treatment
Control group will recieve standard medical therapy including aspirin, statin therapy +/- angiotensin converting enzyme inhibitor or angiotensin receptor blocker and will be observed for three months. Treatment is at the discretion of the primary physician and will differ on case by case basis.
Control group
Active

Outcomes
Primary outcome [1] 258329 0
To correlate high sensitivity C-reactive protein levels with changes in endothelial function as measured by brachial artery flow mediated dilation.
Timepoint [1] 258329 0
3 months. Baseline and 3 month measurement of flow mediated dilation.
Secondary outcome [1] 264038 0
To determine the effect of low dose colchicine on blood inflammatory cytokines (high sensitivity C-reactive protein, interleukin 1, interleukin 6, Tumor necrosis factor alpha and serum amyloid A) via the measurement of inflammatory cytokine levels after phlebotomy using automated analysis.
Timepoint [1] 264038 0
3 months. Baseline and 3 month measurement of inflammatory cytokines.

Eligibility
Key inclusion criteria
18 to 80 years old.
Male and female.
History of proven coronary artery disease by coronary agnigraphy. (>50% stenosis of epicardial coronary artery or requirement for percutaneous coronary intervention)
Stable for >1 month
No significant co-morbidity that will affect followup.
No contraindication to colchicine use.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patient who is not deemed to have stable coronary artery disease.
Mild coronary artery disease.
Advanced heart failure (New York Heart Association grade 3 or 4).
Renal failure with creatnine clearance(<30ml/min/1.73m2).
Known malignancy.
Inflammatory bowel disease.
Requirement for cyclosporine or other drugs that may interact with colchicine.
Known sensitivity to colchicine.
Pregnancy or contemplated pregnancy during the study period.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients recruited from outpatient clinic lists. Patients are randomised to either treatment or control via central randomisation by computer. Allocation occurs after enrollment and consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random Binary number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Patients are randomly assigned to treatment or control group initially and then cross over to the alternate group after a one month washout period. Baseline flow mediated dilation testing and inflammatory marker testing are performed at baseline and after three months participation in both control and treament arms.
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256887 0
Commercial sector/Industry
Name [1] 256887 0
Pfizer Cardiovascular Lipid Research Grant
Country [1] 256887 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pfizer Cardiovascular Lipid Research Grant
Address
CVL Research Grants
PO Box 57
West Ryde NSW 2114
Country
Australia
Secondary sponsor category [1] 256161 0
Hospital
Name [1] 256161 0
Sir Charles Gairdner Hospital
Address [1] 256161 0
Hospital Avenue
Nedlands 6009
WA
Country [1] 256161 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258899 0
Sir Charles Gairdner Hospital Ethics Committee
Ethics committee address [1] 258899 0
Ethics committee country [1] 258899 0
Australia
Date submitted for ethics approval [1] 258899 0
20/02/2008
Approval date [1] 258899 0
19/06/2008
Ethics approval number [1] 258899 0
2008-001

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31107 0
Address 31107 0
Country 31107 0
Phone 31107 0
Fax 31107 0
Email 31107 0
Contact person for public queries
Name 14354 0
Dr Chris Judkins
Address 14354 0
Heart Research Unit
Ground floor, R block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands 6009
WA
Country 14354 0
Australia
Phone 14354 0
+61 414 468 332
Fax 14354 0
Email 14354 0
christopher.judkins@health.wa.gov.au
Contact person for scientific queries
Name 5282 0
Dr Chris Judkins
Address 5282 0
Heart Research Unit
Ground floor, R block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands 6009
WA
Country 5282 0
Australia
Phone 5282 0
+61 414 468 332
Fax 5282 0
Email 5282 0
christopher.judkins@health.wa.gov.au

No information has been provided regarding IPD availability


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
No additional documents have been identified.