Larsen Kristin Tveitan, Forfang Elisabeth, Pennlert Johanna, Glader Eva-Lotta, Kruuse Christina, Wester Per, Ihle-Hansen Hege, Carlsson Maria, Berge Eivind, Al-Shahi Salman Rustam, Bruun Wyller Torgeir, Rønning Ole Morten
Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.
University of Oslo, Institute of Clinical Medicine, Oslo, Norway.
Eur Stroke J. 2020 Dec;5(4):414-422. doi: 10.1177/2396987320954671. Epub 2020 Sep 3.
Many patients with prior intracerebral haemorrhage have indications for antithrombotic treatment with antiplatelet or anticoagulant drugs for prevention of ischaemic events, but it is uncertain whether such treatment is beneficial after intracerebral haemorrhage. STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage will assess (i) the effects of long-term antithrombotic treatment on the risk of recurrent intracerebral haemorrhage and occlusive vascular events after intracerebral haemorrhage and (ii) whether imaging findings, like cerebral microbleeds, modify these effects.
STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage is a multicentre, randomised controlled, open trial of starting versus avoiding antithrombotic treatment after non-traumatic intracerebral haemorrhage, in patients with an indication for antithrombotic treatment. Participants with vascular disease as an indication for antiplatelet treatment are randomly allocated to antiplatelet treatment or no antithrombotic treatment. Participants with atrial fibrillation as an indication for anticoagulant treatment are randomly allocated to anticoagulant treatment or no anticoagulant treatment. Cerebral CT or MRI is performed before randomisation. Duration of follow-up is at least two years. The primary outcome is recurrent intracerebral haemorrhage. Secondary outcomes include occlusive vascular events and death. Assessment of clinical outcomes is performed blinded to treatment allocation. Target recruitment is 500 participants. Recruitment to STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage is on-going. On 30 April 2020, 44 participants had been enrolled in 31 participating hospitals. An individual patient-data meta-analysis is planned with similar randomised trials.
许多既往有脑出血病史的患者有使用抗血小板或抗凝药物进行抗栓治疗以预防缺血性事件的指征，但脑出血后进行此类治疗是否有益尚不确定。脑出血后抗栓治疗研究将评估：（i）长期抗栓治疗对脑出血后复发性脑出血和闭塞性血管事件风险的影响；（ii）脑微出血等影像学表现是否会改变这些影响。
脑出血后抗栓治疗研究是一项多中心、随机对照、开放性试验，针对有抗栓治疗指征的非创伤性脑出血患者，比较开始抗栓治疗与避免抗栓治疗的效果。有血管疾病作为抗血小板治疗指征的参与者被随机分配接受抗血小板治疗或不进行抗栓治疗。有房颤作为抗凝治疗指征的参与者被随机分配接受抗凝治疗或不进行抗凝治疗。随机分组前进行脑部CT或MRI检查。随访时间至少为两年。主要结局是复发性脑出血。次要结局包括闭塞性血管事件和死亡。临床结局评估在对治疗分配不知情的情况下进行。目标招募人数为500名参与者。脑出血后抗栓治疗研究正在进行招募。截至2020年4月30日，31家参与研究的医院已招募了44名参与者。计划对类似的随机试验进行个体患者数据荟萃分析。
