Keeping Oral o Parental AnticoaguLation in the Acute Phase of Cardioembolic Ischemic
试验速览
- 阶段
- 不适用
- 入组人数
- 318
- 试验地点
- 3
- 主要终点
- Symptomatic haemorrhagic transformation
研究概览
简要总结
This is an observational, prospective, multicenter, cohort study in patients with cardioembolic stroke and previous oral or parenteral anticoagulant therapy. Patients in which anticoagulante therapy is mantained will be compared to those in which it is interrupted, in terms of stroke or systemic embolism and haemorrhagic transformation.
详细描述
Observational, prospective, multicenter, cohort study in patients with recent cardioembolic stroke (<24 hours) and previous oral or parenteral anticoagulant therapy (last dose recieved <24hours) . Patients in which anticoagulante therapy is mantained will be compared to those in which it is interrupted. The decision to mantain or interrumpt the anticoagulant therapy is made by the treating physician as hospital protocol. Stroke recurrence, haemorrhagic transformation at 90 days are evalauted and also complication during the hospitalization and functional outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic stroke of less than 24 hours since beginning of symptoms or last seen normal
- •Mayor cardioembolic source (atrial fibrilation or flutter, mechanical heart valve prosthesis, recient miocardic infarction, rheumatic mitral valve stenosis, dilated cardiomyopathy, atrial myxoma, left ventricular focal akynesia.
- •Previous treatment with oral anticoagulants (vitamin K antagonists or direct oral anticoagulants), having received the last dose within the previous 24 hours. Treatment with intravenous or subcutaneos heparin is also valid.
- •Age >18 years-old
- •Signed informed consent (by patient or representative)
排除标准
- •History of Intracraneal or extracraneal haemorrhage that contraindicates anticoagulant therapy
- •Patients treated with intravenous thrombolysis as a reperfusion therapy
- •Intracraneal haemorrhage on initial CT scan
- •Health status with a short survival prevision
- •Patients in which a neurosurgery intervention could be indicated
- •Child-bearing woman or in breast-feeding period.
结局指标
主要结局
Symptomatic haemorrhagic transformation
时间窗: 90 days
Symptomatic haemorrhagic transformation defined by the SITS criteria and supported by neuroimaging
Ischemic stroke recurrence
时间窗: 90 days
recurrence of ischemic stroke noticied by changes in neurologic status and supported by neuroimaging
次要结局
- Early symptomatic haemorrhagic transformation(Day 1 or day 7)
- Early radiologic haemorrhagic transformation(Day 1 or day 7)
- Mortality(Day 7)
- Neurologic status(Day 90)
- Functional status(Day 90)
- Systemic embolism(Day 1, day 7 or day 90)
- Major extracraneal haemorrhagic complication(Day 1, day 7 or day 90)
- Early ischemic stroke recurrence(Day 1 or day 7)