None listed
Conditions
Brief summary
Inflammation is central to the development and progression of atherosclerosis. Neutrophils are the most abundant immune cell in circulation and contribute to atherosclerosis-associated inflammation. Colchicine is an anti-inflammatory agent currently approved for the treatment of gout, familial Mediterranean fever and acute/recurrent pericarditis. There is mounting evidence that indicates colchicine is effective at reducing ACS recurrence rates by inhibiting specific inflammatory pathways. An anti-inflammatory effect of colchicine on neutrophils has been noted in patients with vasculitis, although this has not been examined in those with coronary artery disease. Colchicine use has been proven to be safe, well tolerated and is inexpensive and readily available. The aim of this study is to assess the acute effect of colchicine (1.5 mg orally) on neutrophil function in patients with coronary artery disease. We hypothesis that colchicine will inhibit neutrophil hyper-reactivity seen in these patients.
Interventions
1.5 mg colchicine will be administered orally in two doses – 1 mg followed by 0.5 mg one hour later.
Patients presenting with an acute coronary syndrome or stable angina will be recruited shortly after admission. Written informed consent will be obtained from all study participants. Prior to randomisation a peripheral venous blood sample (20 mL) will be collected. Patients will then be randomised to receive either colchicine (as above) plus standard medical care or standard medical care alone.
1.5 mg colchicine will be administered orally in two doses – 1 mg followed by 0.5 mg one hour later. Patients presenting with an acute coronary syndrome or stable angina will be recruited shortly after admission. Written informed consent will be obtained from all study participants. Prior to randomisation a peripheral venous blood sample (20 mL) will be collected. Patients will then be randomised to receive either colchicine (as above) plus standard medical care or standard medical care alone. 24-hours post intervention a further 20 mL peripheral venous blood sample will be collected.
Sponsors
A/Prof Sanjay Patel
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age >= 18 years ACS patients < 48 hours post presentation
Exclusion criteria
Colchicine treatment for another cause Severe liver disease Renal insufficiency with creatinine clearance < 45 ml/min Calcineurin inhibitor treatment Hypersensitivity to colchicine Haematological malignancy or antineoplastic therapy Thrombocytopenia or leukopenia Pregnancy, lactating women or women at risk of pregnancy Strong CYP3A4 inhibitors Chronic inflammatory bowel disease
Outcome results
None listed