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

COlchicine 用于预防非心源性栓塞性中风中的血管炎症 - 一项随机临床试验 (CONVINCE)。

• 批准号: 397530000
• 负责人: Professor Dr. Karl-Heinz Jöckel
• 金额: --
• 依托单位: Institut für Medizinische Informatik, Biometrie und Epidemiologie (IMIBE)
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/397530000?language=en
• 关键词: COlchicine; prevention; Vascular; Inflammation; Non

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.

炎症导致不稳定的动脉粥样硬化斑块、血栓栓塞性中风、心肌梗死和血管死亡。在冠心病患者的随机试验中，秋水仙碱(一种具有多种抗炎作用的微管蛋白抑制剂)减少了复发的血管事件。假设：与常规护理相比，小剂量秋水仙碱(每天0.5毫克)抗炎治疗加上常规护理将减少非心源性栓塞型、缺血性中风或短暂性脑缺血发作患者的血管复发事件。设计：SIMPLE是一项多中心、国际性、前瞻性、随机化、开放标签、盲目终点评估(PROBE)控制的第三阶段临床试验，共有3154名参与者参加。干预措施是秋水仙碱0.5毫克/天，常规护理与常规护理(抗血小板、降脂、抗高血压治疗、生活方式建议)比较。纳入的患者至少40岁，在随机选择的72小时-28天内，患有非严重的缺血性中风(改良兰金评分≤3)或高危短暂性脑缺血发作(ABCD2&GT；3，或阳性弥散加权成像，或颅颈动脉狭窄)，符合条件的卒中/短暂性脑缺血发作最有可能由大动脉狭窄、腔隙疾病或隐源性栓塞症引起。排除因素包括心脏栓塞或其他明确原因(如夹层)引起的中风/短暂性脑缺血发作，秋水仙碱的禁忌症(包括潜在的药物相互作用)，或不能参与临床试验。预期的中位随访期为36个月。主要的分析将是意向治疗。主要结果是首次复发缺血性中风、心肌梗死、心脏骤停或因不稳定心绞痛(非致命性或致命性)住院的时间。时间表：SIMPLE目前正在14个国家(13个欧洲和加拿大)进行招聘。截至2022年2月，2700名参与者被随机分配(德国为342名)。在计划纳入524名德国参与者之后，这项赠款申请将确保他们在德国的25个中心进行后续行动。摘要：SIMPLE将提供高质量的随机数据，说明使用秋水仙碱进行抗炎治疗对中风后二级预防的有效性和安全性。