None listed
Conditions
Brief summary
Inflammation is a key component in the cause of ischemic stroke. Colchicine is a commonly used anti-inflammatory medication approved for the treatment of gout, Familial Mediterranean Fever, and acute/recurrent pericarditis. There is an increasing body of evidence in the literature supporting a beneficial role of long-term colchicine therapy in prevention of cardiovascular disease. Low-dose colchicine use has also been proven to be safe, well tolerated and is inexpensive and readily available. The aim of this trial is to assess the effect of low-dose colchicine (0.5mg/daily) in addition to optimal medical therapy of cardiovascular outcomes in stroke patients with evidence of persistent coronary inflammation (based on hs-CRP). We hypothesise that addition of colchicine to optimal medical therapy in patients post-stroke, who have biomarker evidence of persistent inflammation will reduce recurrent cardiovascular events.
Interventions
Oral Colchicine 0.5 mg tablet taken daily for median of 3 years. Eligible and consenting participants will be registered and then commenced on Run-In treatment consisting of 1 oral tablet (0.5mg of colchicine) a day for 28 days additional to standard of care. The Run-In treatment will be dispensed to participants in a single blinded manner. Upon completion of the Run-In treatment participants will be asked to return to site for a safety and compliance check before being randomised to receive eit
Oral Colchicine 0.5 mg tablet taken daily for median of 3 years. Eligible and consenting participants will be registered and then commenced on Run-In treatment consisting of 1 oral tablet (0.5mg of colchicine) a day for 28 days additional to standard of care. The Run-In treatment will be dispensed to participants in a single blinded manner. Upon completion of the Run-In treatment participants will be asked to return to site for a safety and compliance check before being randomised to receive either oral Colchicine 0.5mg taken daily or matched oral Placebo tablet taken daily for a median of 3 years.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Presentation with an ischaemic stroke without major disability (MRS less than or equal to 3 - at time of registration [4-52 weeks]) OR clinical TIA with brain imaging evidence of acute infarction and commenced on OMT 2. hs-CRP greater than or equal to 1.0mg/L (at time of registration) 4 to 52 weeks post-stroke event 3. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
Exclusion criteria
1. Suspected cardio-embolic stroke/ TIA, that is probably caused by a. Identified atrial fibrillation (permanent or paroxysmal), b. Other identified cardiac source (intra-cardiac thrombus, endocarditis, metallic heart valve, low ejection fraction <30%), c. Stroke/ TIA caused by dissection, endo-carditis, paradoxical embolism, drug use, venous thrombosis, within 48 hours after carotid or cardiac surgery, 2. Hypercoagulability states, 3. Migraines related to the index stroke or TIA/ Migrainous Strokes, or inherited cerebrovascular disorders. 4. Any known intolerance to Colchicine 5. Pre-existing Colchicine treatment for greater than 7 days within the last 3 months 6. Current active myopathy with creatine kinase (CK) >3x upper limit of normal. 7. Severe liver disease or aminotransferase level >3 x upper limit of normal, within the last 3 months 8. Persistent Blood dyscrasia (white cell count or platelet count <lower limit of normal), within the last 3 months 9. Estimated glomerular filtration rate (eGFR) <30 ml/min per 1.73m2 at time of registration 10. Prior or current therapy with a strong CYP3A4 inhibitor or inducer or calcineurin inhibitor 11. Active autoimmune disease or chronic inflammatory bowel disease (defined as any disease requiring long-term or frequent immunosuppression) 12. Any other conditions that would not make it possible to participate in the trial
Outcome results
None listed