Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke (NCT02898610) | Clinical Trial Compass
CompletedPhase 3
Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke
Belgium3,154 participantsStarted 2016-12-12
Plain-language summary
This study evaluates the use of Colchicine in adults over 40 years of age who have suffered an ischaemic stroke or transient ischaemic attack NOT caused by cardiac embolism or other defined causes. Patients will be randomised to 0.5 mg/day of Colchicine plus usual care, or to usual care alone.
To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (defined as antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice) compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, hospitalization for unstable angina and vascular death after ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other defined causes unrelated to atherosclerosis
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. Written informed consent consistent with ICH-GCP guidelines and local laws signed prior to all trial-related procedures.
✓. Age 40 years or greater
✓. Either,
✓. Qualifying stroke/TIA probably caused by large artery stenosis, small artery occlusion (lacunar stroke), or cryptogenic embolism, with cardiac embolism or other defined stroke mechanism deemed unlikely in the opinion of the treating physician.
✓. GFRgreater than or equal to 50 ml/min.
✓. In the opinion of the treating physician, patient is medically-stable, capable of participating in a randomised trial, and willing to attend follow-up.
Exclusion criteria
✕. Cardio-embolic stroke/TIA, probably caused by identified atrial fibrillation (permanent or paroxysmal), in the opinion of the treating physician.
✕. Cardio-embolic stroke/TIA probably caused by other identified cardiac source (intra-cardiac thrombus, endocarditis, metallic heart valve, low ejection fraction \<30%), in the opinion of the treating physician.
✕. Stroke/TIA caused by dissection, endocarditis, paradoxical embolism, drug use, venous thrombosis, within 48 hours aftercarotid or cardiac surgery, hypercoagulability states, migraine, or inherited cerebrovascular disorders (eg. Fabry's disease, CADASIL), in the opinion of the treating physician.
✕. History of myopathy or myalgias with raised creatine kinase (CK) on statin therapy.
✕. Blood dyscrasia defined as anaemia (haemoglobin \<10g/dL), thrombocytopenia (platelet count \<150 x109/L) or leucopenia (white cell count \<4 x109/L) at randomisation.
✕. Impaired hepatic function (transaminases greater than twice upper limit of normal) at randomisation.
✕. Concurrent treatment with moderate or strong CYP3A4 inhibitors (clarithromycin, erythromycin, telithromycin, other macrolide antibiotics, ketoconazole, itraconazole, voriconazole, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil, diltiazem, quinidine, digoxin, disulfiram) or P-gp inhibitors (cyclosporine) at randomisation.
✕. Symptomatic peripheral neuropathy and pre-existing progressive neuromuscular disease