CONCISE COlchicine iN Circulating Inflammatory markers after StrokE

Korábbi kezelés

• Concurrent treatment with contra-indicated drugs: CYP3A4 inhibitors (clarithromycin, erythromycin, telithromycin, macrolides, ketoconazole, itraconazole, voriconazole, tolbutamide, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil, diltiazem, quinidine, digoxin, disulfiram) or P-gp inhibitors (cyclosporine) at screening.

Más betegség

• Stroke or TIA likely caused by identified atrial fibrillation (permanent or paroxysmal)
• Requirement for colchicine therapy for acute gout or gout prevention or other rheumatological disorder.
• Known sensitivity or 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.
• History of myalgia with raised CK on statin therapy
• 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.

Laborértékek

• Stroke or TIA caused by other identified cardiac source (intracardiac thrombus, endocarditis, metallic heart value, low ejection fraction <30%)
• Blood dyscrasia (Hb <10g/dl, Plt <150x1o^9/L, WCC <4x10^9/L) or other history of blood dyscrasia requiring follow up with haematology.
• Impaired hepatic function (transaminases >twice ULN)

Egyéb

• Women of childbearing potential. (Must be >24 months free of menstrual periods)
• Patient concurrently enrolled in CONVINCE trial.

• Prior ischaemic stroke or ischaemic attack.
• Living at home and independent (walking without the aid of another person, but may have some help for daily activities) without cognitive impairment causing limitation of daily function.
• Medically-stable, and capable of participating in a research study and likely to follow study procedures, in the opinion of the study physician
• Willing to provide informed consent
• Age >18 years and <90 years
• No history of chronic kidney disease and eGFR>50ml/min measured during screening phase
• Serum hsCRP³2mg/L measured within 6 months of study entry
• History of ischaemic stroke or TIA defined as a. Cerebral, spinal cord or retinal ischaemia based on neuropathological or neuroimaging evidence or clinical evidence of permanent injury. TIA= neurological dysfunction caused by focal cerebral or retinal ischaemia with clinical symptoms lasting <24 hours.
• Presence of atheroma defined as: - intra-cranial or extra-cranial atheroma causing >30% stenosis or occlusion ipsilateral to the infarct AND/OR - Any atheroma proximal to the infarct in patients with cryptogenic stroke/ESUS in whom an alternative mechanism if not felt to be more likely in the opinion of the investigator AND/OR - Patient has a history of ischemic heart disease (IHD) or peripheral arterial disease (PAD), or has undergone revascularisation procedures for IHD or PAD.