CTIS2023-506967-33-00进行中（未招募）1 期
CONCISECOlchicine iN Circulating Inflammatory markers after StrokE - CONCISE
niversity College Dublin0 个研究点目标入组 120 人开始时间: 2023年10月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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