COlchicine for prevention of Vascular Inflammation in Non-CardioEmbolic stroke - a randomised clinical trial (CONVINCE). German Extension

炎症导致不稳定的动脉粥样硬化斑块、血栓栓塞性中风、心肌梗死和血管性死亡。在冠心病患者的随机试验中，秋水仙碱（一种具有多效性抗炎作用的微管蛋白抑制剂）减少了血管事件的复发。 假设：与单纯常规治疗相比，低剂量秋水仙碱（0.5mg/天）抗炎治疗加常规治疗可减少非心源性栓塞、缺血性卒中或TIA患者的复发性血管事件。设计图：CONVINCE是一项在3154名受试者中开展的多中心、国际、前瞻性、随机、开放标签、设盲终点评估（PROBE）对照III期临床试验。干预是秋水仙碱0.5 mg/天和常规护理与单独常规护理（抗血小板、降脂、抗高血压治疗、生活方式建议）。纳入的患者年龄至少为40岁，在随机化72小时-28天内患有非重度缺血性卒中（改良兰金评分≤3）或高危TIA（ABCD 2> 3，或DWI阳性，或颅颈动脉狭窄），符合条件的卒中/TIA最可能由大动脉狭窄、腔隙性疾病或隐源性栓塞引起。排除由心源性栓塞或其他确定原因（例如夹层）引起的卒中/TIA、秋水仙碱禁忌症（包括潜在的药物相互作用）或无法参加临床试验。预期中位随访时间为36个月。主要分析将按意向治疗进行，主要结局是至首次复发缺血性卒中、心肌梗死、心脏骤停或因不稳定型心绞痛住院（非致死性或致死性）的时间。时间表：CONVINCE目前在14个国家（13个欧洲国家和加拿大）招募。截至2022年2月，2700名受试者接受了随机分组（德国342名）。在计划纳入524名德国参与者后，该资助申请将确保他们在德国的25个中心进行随访。 总结：CONVINCE将提供高质量的随机数据，以了解秋水仙碱抗炎治疗用于卒中后二级预防的有效性和安全性。

Inflammation contributes to unstable atherosclerotic plaque, thromboembolic stroke, myocardial infarction and vascular death. In randomised trials in patients with coronary disease, colchicine (a tubulin inhibitor with pleiotropic anti-inflammatory effects) reduced recurrent vascular events. Hypothesis: Anti-inflammatory therapy with low-dose colchicine (0.5mg/day) plus usual care will reduce recurrent vascular events in patients with non-cardioembolic, ischemic stroke or TIA compared with usual care alone. Design: CONVINCE is a multi-centre, international, Prospective, Randomised Open-label, Blinded-Endpoint assessment (PROBE) controlled Phase 3 clinical trial in 3154 participants. The intervention is colchicine 0.5 mg/day and usual care versus usual care alone (antiplatelet, lipid-lowering, antihypertensive treatment, lifestyle advice). Included patients are at least 40 years old, with non-severe ischaemic stroke (modified Rankin score ≤3) or high-risk TIA (ABCD2 > 3, or positive DWI, or cranio-cervical artery stenosis) within 72 hours-28 days of randomisation, with qualifying stroke/TIA most likely caused by large artery stenosis, lacunar disease, or cryptogenic embolism. Exclusions are stroke/TIA caused by cardio-embolism or other defined cause (e.g. dissection), contra-indication to colchicine (including potential drug interactions), or incapacity for participation in a clinical trial. The anticipated median follow-up will be 36 months. The primary analysis will be by intention-to-treat. The primary outcome is time to first recurrent ischaemic stroke, myocardial infarction, cardiac arrest, or hospitalisation with unstable angina (non-fatal or fatal). Schedule: CONVINCE is currently recruiting in 14 countries (13 European and Canada). Until February 2022, 2700 participants have been randomized (342 in Germany). After planned inclusion of 524 German participants, this grant application will secure their follow-up in 25 centers in Germany. Summary: CONVINCE will provide high-quality randomised data on the efficacy and safety of anti-inflammatory therapy with colchicine for secondary prevention after stroke.