Traenka Christopher, Gensicke Henrik, Schaedelin Sabine, Luft Andreas, Arnold Marcel, Michel Patrik, Kägi Georg, Kahles Timo, Nolte Christian H, Kellert Lars, Rosenbaum Sverre, Sztaizel Roman, Brehm Alex, Stippich Christoph, Psychogios Marios, Lyrer Philippe, Engelter Stefan T
Department of Neurology and Stroke Center, University Hospital Basel and University of Basel, Basel, Switzerland.
Neurology and Neurorehabilitation, University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland.
Eur Stroke J. 2020 Sep;5(3):309-319. doi: 10.1177/2396987320921151. Epub 2020 Jun 29.
The type of antithrombotic treatment in cervical artery dissection patients is still a matter of debate. Most physicians prefer anticoagulants over antiplatelet agents for stroke prevention. However, this approach is not evidence-based and antiplatelets might be as safe and as effective. The 'Biomarkers and Antithrombotic Treatment in Cervical Artery Dissection' ('TREAT-CAD') trial (clinicaltrials.gov: NCT02046460) compares Aspirin to oral anticoagulants (vitamin K antagonists) with regard to efficacy and safety by using both clinical and imaging surrogate outcome measures. TREAT-CAD tests the hypothesis, that aspirin is as safe and effective as vitamin K antagonists.
TREAD-CAD is a rospective, andomised controlled, pen-labelled, multicentre, non-inferiority trial with linded assessment of outcome vents (PROBE-design). Key eligibility criteria are (i) clinical symptoms attributable to cervical artery dissection and (ii) verification of the cervical artery dissection diagnosis by established magnetic resonance imaging criteria. Patients are randomised to receive either Aspirin 300 mg daily or vitamin K antagonists for 90 days.
Primary outcomes are assessed at 14 ± 10 days (magnetic resonance imaging and clinical examination) and at 90 ± 30 days (clinical examinations). The primary endpoint is a composite outcome measure - labelled erebrovascular schemia, major emorrhagic events or eath (CIHD) - and includes (i) occurrence of any stroke (including retinal infarction), (ii) new ischaemic lesions on diffusion-weighted magnetic resonance imaging, (iii) any major extracranial haemorrhage, (iv) any symptomatic intracranial haemorrhage, (v) any new haemorrhagic lesion visible on paramagnetic-susceptible sequences and (vi) death.
After database closure, (i) central verification of cervical artery dissection diagnosis will be done by two experienced raters, (ii) adjudication of outcome events will be performed by independent adjudication committees, separately for clinical and imaging outcomes. The primary analysis will be done on the per protocol data set. The targeted sample size consists of 169 evaluable patients in the per protocol data set.
TREAT-CAD is testing the non-inferiority of Aspirin versus vitamin K antagonists treatment in patients with symptomatic cervical artery dissection by combined clinical and magnetic resonance imaging outcomes.
颈动脉夹层患者的抗血栓治疗类型仍存在争议。大多数医生在预防卒中方面更倾向于使用抗凝剂而非抗血小板药物。然而，这种方法并非基于证据，抗血小板药物可能同样安全有效。“颈动脉夹层的生物标志物与抗血栓治疗”（“TREAT-CAD”）试验（clinicaltrials.gov：NCT02046460）通过使用临床和影像学替代结局指标，比较了阿司匹林与口服抗凝剂（维生素K拮抗剂）的疗效和安全性。TREAT-CAD检验了阿司匹林与维生素K拮抗剂同样安全有效的假设。
TREAT-CAD是一项前瞻性、随机对照、开放标签、多中心、非劣效性试验，采用结局事件的盲法评估（PROBE设计）。主要入选标准为：（i）归因于颈动脉夹层的临床症状；（ii）根据既定的磁共振成像标准对颈动脉夹层诊断进行验证。患者被随机分为每日接受300毫克阿司匹林或维生素K拮抗剂治疗90天。
主要结局在14±10天（磁共振成像和临床检查）以及90±30天（临床检查）进行评估。主要终点是一个复合结局指标——标记为脑血管缺血、重大出血事件或死亡（CIHD）——包括：（i）任何卒中的发生（包括视网膜梗死）；（ii）扩散加权磁共振成像上新发的缺血性病变；（iii）任何重大的颅外出血；（iv）任何有症状的颅内出血；（v）在顺磁敏感序列上可见的任何新的出血性病变；（vi）死亡。
数据库关闭后，（i）将由两名经验丰富的评估者对颈动脉夹层诊断进行中心验证；（ii）结局事件的判定将由独立的判定委员会分别针对临床和影像学结局进行。主要分析将基于符合方案数据集进行。目标样本量包括符合方案数据集中169例可评估患者。
TREAT-CAD正在通过综合临床和磁共振成像结局来检验阿司匹林与维生素K拮抗剂治疗有症状颈动脉夹层患者的非劣效性。
