Colchicine After Stroke Event to Prevent Event Recurrence (CASPER): A randomised trial to evaluate the efficacy of oral Colchicine in high-risk patients with atherosclerosis-associated inflammation post-Stroke

niversity of Sydney0 个研究点目标入组 1,500 人开始时间: 2021年10月20日最近更新: 2024年4月8日

适应症

试验速览

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•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

•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 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

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