CONCISECOlchicine iN Circulating Inflammatory markers after StrokE

Phase 1

Conditions: Stroke
MedDRA version: 22.1Level: LLTClassification code: 10067816Term: Cardioembolic stroke Class: 10029205
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: CTIS2023-506967-33-00

Lead Sponsor: niversity College Dublin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

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.

Exclusion Criteria

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., Women of childbearing potential. (Must be >24 months free of menstrual periods), Patient concurrently enrolled in CONVINCE trial., 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 <150x1o^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 (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., 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.