COlchicine iN Circulating Inflammatory Markers After StrokE (CONCISE) (CONCISE)
Ischemic Stroke, Atherosclerosis
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring hsCRP, ischaemic stroke, atherosclerosis
Eligibility Criteria
Inclusion Criteria: Free of chronic kidney disease and eGFR>50ml/min on baseline blood tests Serum hsCRP≥2mg/L measured during the screening phase or on routine bloods in the year prior to recruitment. History of ischaemic stroke or TIA presence of atheroma, including intracranial or extracranial atheroma causing ≥30% stenosis or occlusion ipsilateral to the infarct; any atheroma proximal to the infarct in patients with cryptogenic stroke or ESUS in whom an alternative mechanism is not felt to be more likely in the opinion of the physician; history of ischaemic heart disease, peripheral arterial disease or has undergone revascularisation procedures for either. Exclusion Criteria: Stroke or TIA likely caused by identified atrial fibrillation (permanent or paroxysmal) Stroke or TIA caused by other identified cardiac source (intracardiac thrombus, endocarditis, metallic heart value, low ejection fraction <30%) History of myalgia with raised CK on statin therapy Blood dyscrasia (Hb <10g/dl; Plt <150x10^9/L; WCC <4x10^9/L) or other history of blood dyscrasia requiring follow-up with Haematology Impaired hepatic function (transaminases >twice ULN) Concurrent treatment with contra-indicated drugs: CYP3A4 inhibitors (e.g. clarithromycin, erythomycin, telithromycin, macrolides, ketoconazole, itraconazole, voriconazole, tolbutamide, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil, diltiazem, quinidine, digoxin, disulfiram) or P-GP inhibitors (e.g. cyclosporine) at screening Symptomatic peripheral neuropathy or progressive neuromuscular disease Pre-existing inflammatory bowel disease, Crohn's disease, Ulcerative colitis or chronic diarrhoea Pre-existing inflammatory condition, intercurrent infection or other indication for regular anti-inflammatory therapies, e.g. steroid, NSAIDs, immunosuppressants. Requirement for colchicine therapy for acute gout or gout prevention or other rheumatological disorder. Known sensitivity of allergy to colchicine. Active malignancy or known Hepatitis B, C or HIV infection. Dementia or cognitive impairment sufficient to impair independence in basic activities of daily living. People of childbearing potential (Must be >24 months free of menstrual periods) Patient concurrently enrolled in the CONVINCE trial.
Sites / Locations
- Stroke Clinical Trials Network Ireland
Arms of the Study
Arm 1
Other
Single Arm Study
Paired cohort before and after study. Each participant will act as their own control. All participants will receive the intervention: study drug colchicine 0.5mg orally once daily for a treatment period of 30 days.