Background Cervical artery dissection is a major cause of stroke in young people (aged <50 years). Historically, clinicians have preferred using oral anticoagulation with vitamin K antagonists for patients with cervical artery dissection, although some current guidelines-based on available evidence from mostly observational studies-suggest using aspirin. If proven to be non-inferior to vitamin K antagonists, aspirin might be preferable, due to its ease of use and lower cost. We aimed to test the non-inferiority of aspirin to vitamin K antagonists in patients with cervical artery dissection.Methods We did a multicentre, randomised, open-label, non-inferiority trial in ten stroke centres across Switzerland, Germany, and Denmark. We randomly assigned (1:1) patients aged older than 18 years who had symptomatic, MRI-verified, cervical artery dissection within 2 weeks before enrolment, to receive either aspirin 300 mg once daily or a vitamin K antagonist (phenprocoumon, acenocoumarol, or warfarin; target international normalised ratio INR 2 ? 0-3 ? 0) for 90 days. Randomisation was computer-generated using an interactive web response system, with stratification according to participating site. Independent imaging core laboratory adjudicators were masked to treatment allocation, but investigators, patients, and clinical event adjudicators were aware of treatment allocation. The primary endpoint was a composite of clinical outcomes (stroke, major haemorrhage, or death) and MRI outcomes (new ischaemic or haemorrhagic brain lesions) in the per-protocol population, assessed at 14 days (clinical and MRI outcomes) and 90 days (clinical outcomes only) after commencing treatment. Non-inferiority of aspirin would be shown if the upper limit of the two-sided 95 CI of the absolute risk difference between groups was less than 12 (non-inferiority margin). This trial is registered with ClinicalTrials.gov, NCT02046460.
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机译：背景 颈动脉夹层是年轻人（<50 岁）中风的主要原因。从历史上看，临床医生更倾向于对颈动脉夹层患者使用口服抗凝药物和维生素 K 拮抗剂，尽管目前一些指南（基于大多数观察性研究的现有证据）建议使用阿司匹林。如果证明阿司匹林不劣于维生素K拮抗剂，阿司匹林可能更可取，因为它易于使用且成本较低。我们旨在测试阿司匹林在颈动脉夹层患者中对维生素K拮抗剂的非劣效性。方法 我们在瑞士、德国和丹麦的10个卒中中心进行了一项多中心、随机、开放标签、非劣效性试验。我们随机分配（1：1）年龄在入组前2周内出现症状、经MRI验证的颈动脉夹层的18岁以上患者接受阿司匹林300mg每日一次或维生素K拮抗剂（苯丙香豆素、醋硝香豆素或华法林;目标国际标准化比值[INR] 2 ？ 0-3 ？ 0）90天。随机化是使用交互式网络响应系统计算机生成的，并根据参与站点进行分层。独立的影像学核心实验室裁决者对治疗分配不知情，但研究者、患者和临床事件裁决者都知道治疗分配。主要终点是符合方案的人群的临床结局（卒中、大出血或死亡）和MRI结局（新的缺血性或出血性脑病变）的综合结果，在开始治疗后14天（临床和MRI结局）和90天（仅临床结局）进行评估。如果组间绝对风险差异的双侧 95% CI 的上限小于 12%（非劣效性边际），则显示阿司匹林的非劣效性。该试验已在 ClinicalTrials.gov 注册，NCT02046460。
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