NCT07139314招募中不适用
Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation: a Randomised Controlled Trial
Capital Medical University38 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年9月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 38
- 主要终点
- Composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, and all-cause death
研究概览
简要总结
This study evaluates the safety and efficacy of early versus delayed initiation of direct oral anticoagulants (DOACs) in patients with acute ischemic stroke related to atrial fibrillation who develop hemorrhagic transformation after endovascular treatment.
详细描述
This is a multicenter, prospective, open-label, randomized controlled trial evaluating the safety and efficacy of different initiation timings of direct oral anticoagulants (DOACs) therapy in patients with acute ischemic stroke related to atrial fibrillation who develop hemorrhagic transformation after emergency endovascular therapy (EVT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Aged 18 years or over.
- •Clinical diagnosis of large vessel occlusion acute ischemic stroke.
- •Emergency endovascular treatment was performed within 24 hours of stroke onset.
- •Atrial fibrillation (including paroxysmal, persistent or permanent atrial fibrillation), confirmed by at least one of the following:
- •12-lead ECG recording;
- •Inpatient ECG telemetry;
- •Prolonged ECG monitoring (e.g. Holter monitor);
- •Previously established diagnosis of atrial fibrillation verified by medical records.
- •CT or MRI demonstrating one of the following findings:
- •Parenchymatous hematoma type 1: defined as hematoma occupying less than 30% of the infarcted tissue, no substantive mass effect (Heidelberg classification);
- •Parenchymatous hematoma type 2: defined as heamtoma occupying 30% or more of the infarcted tissue, with obvious mass effect (Heidelberg classification);
- •Intracerebral hemorrhage outside the infarcted brain tissue or intracranial-extracerebral hemorrhage (Heidelberg classification).
- •Time from stroke onset to randomization ranged from 7 days to 4 weeks.
- •Written informed consent obtained from the patient or a legally authorized representative.
排除标准
- •Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis, recent surgery, or myocardial infarct).
- •Contraindication to the use of direct oral anticoagulants (DOACs):
- •Known allergy or intolerance to both factor Xa inhibitors and direct thrombin inhibitors;
- •Definite indication for vitamin K antagonist (VKA) treatment (e.g. mechanical heart valve, valvular atrial fibrillation);
- •Severe renal impairment (defined as creatinine exceeding 1.5 times of the upper limit of normal range) and significant hepatic dysfunction (defined as ALT or AST > twice the upper limit of normal range) ;
- •Concomitant use of medications with significant interactions with DOACs, including azole antifungals, HIV protease inhibitors, or strong CYP3A4 inducers;
- •Baseline platelet count < 100 x 109/L;
- •History of coagulopathy or systemic hemorrhage.
- •Prior DOAC use within 48 hours of stroke onset, or recent treatment with vitamin K antagonist (VKA) leading to INR ≥1.7 at randomization.
- •Pregnant or breastfeeding women, or positive pregnancy test at admission.
- •History of major surgery or severe trauma within 1 month prior to stroke onset.
- •History of active bleeding within 1 month prior to stroke onset (e.g. gastrointestinal bleeding, urinary tract bleeding).
- •Dual antiplatelet therapy at baseline, or strong likelihood of requiring dual antiplatelet therapy during the trial.
- •Evidence of cerebral amyloid angiopathy.
- •CT or MRI evidence of non-stroke pathology likely to account for the presenting clinical symptoms (e.g. mass lesion, encephalitis).
- •Modified Rankin scale (mRS) score > 1 prior to stroke onset.
- •Inability to complete the 90-day follow-up.
- •Currently participating in another drug clinical trial.
- •Any other reason deemed by the investigator to make the patient unsuitable for participation in the trial.
研究组 & 干预措施
Early anticoagulation
Active Comparator
Early initiation of any direct oral anticoagulant (DOAC) within 4 weeks of the onset of acute ischemic stroke
干预措施: Early anticoagulation (Drug)
Delayed anticoagulation
Experimental
Delayed initiation of any direct oral anticoagulant (DOAC) between 4-8 weeks of the onset of acute ischemic stroke
干预措施: Delayed anticoagulation (Drug)
结局指标
主要结局
Composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, and all-cause death
时间窗: 90 days
次要结局
- Incidence of myocardial infarction(90 days)
- Proportion of patients achieving mRS 0-3 at 90 Days(90 days)
- Quality of life at 90 days assessed by EuroQol 5 Dimensions 5 level questionnaire [EQ-5D-5L](90 days)
- Incidence of vascular death(90 days)
- Incidence of recurrent ischemic stroke(90 days)
- Incidence of venous thromboembolism(90 days)
- Incidence of systemic embolism(90 days)
- Proportion of patients achieving mRS 0-2 at 90 Days(90 days)
- Length of hospital stay for stroke-related care(90 days)
- All-cause mortality(90 days)
- Incidence of major extracranial bleeding(90 days)
- Incidence of symptomatic intracranial hemorrhage (sICH)(90 days)
- Incidence of recurrent ischemic stroke(90 days and 1 year)
- Proportion of patients achieving mRS 0-2(90 days and 1 year)
- Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire [EQ-5D-5L](90 days and 1 year)
- Incidence of vascular death(90 days and 1 year)
- All-cause mortality(90 days and 1 year)
- Incidence of symptomatic intracranial hemorrhage (sICH)(90 days and 1 year)
- Incidence of major extracranial bleeding(90 days and 1 year)
研究者
Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Capital Medical University
研究点 (38)
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