2025-521762-99-00招募中3 期
Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants – a multicentre randomised placebo-controlled clinical trial
University Medical Center Hamburg-Eppendorf10 个研究点 分布在 1 个国家目标入组 668 人开始时间: 2025年12月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 668
- 试验地点
- 10
- 主要终点
- Functional outcome (modified Rankin Scale, mRS) 90 days after randomisation
研究概览
简要总结
To assess whether intravenous thrombolysis with tenecteplase 0.25 mg/kg improves functional outcome after acute ischemic stroke in patients taking direct oral anticoagulants compared to placebo.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Clinical diagnosis of acute stroke with disabling deficit
- •National Institutes of Health Stroke Scale (NIHSS) score at least 2
- •Recent intake (within 48 hours prior to enrolment) of a direct oral anticoagulant (apixaban, rivaroxaban, edoxaban, or dabigatran)
- •No evidence of any intracranial haemorrhage on cerebral imaging (CT or MRI) performed after stroke onset and no earlier than 60 minutes before enrolment
- •Stroke symptoms not known to have been present for > 6 h
- •For patients not known to have been awake and without acute stroke symptoms within 4.5 hours prior to enrolment, additional imaging criteria must be satisfied: a) If stroke symptoms are known to have been present for > 4.5 h (late time window): core/penumbra mismatch on MR or CT perfusion imaging; b) If stroke symptoms are not known to have been present for > 4.5 h (unknown time window): core/penumbra mismatch on MR or CT perfusion imaging; or DWI/FLAIR mismatch on MR imaging.
排除标准
- •Contraindication to intravenous thrombolysis, except DOAC therapy
- •Reversal or planned reversal of anticoagulation with idarucizumab or andexanet alfa
- •Concomitant therapy with antithrombotic medications, except DOACs
- •Anticipated stenting of cervical or intracranial artery within 12 hours
- •Anticipated coronary angioplasty within 12 hours
- •Any anticipated surgical intervention within 12 hours
- •Significant pre-stroke disability (mRS > 3)
结局指标
主要结局
Functional outcome (modified Rankin Scale, mRS) 90 days after randomisation
Functional outcome (modified Rankin Scale, mRS) 90 days after randomisation
次要结局
- Safety Endpoint: Major haemorrhage (ISTH) within 72 hours
- Safety Endpoint: Orolingual angioedema within 4 hours
- Safety Endpoint: Death or dependency (mRS score 4–6) after 90 days
- Safety Endpoint: All-cause mortality after 90 days
- Safety Endpoint: Time to death right-censored at 90 days
- Efficacy Endpoint: Nondisabled (mRS score ≤ 1) functional outcome after 90 days
- Efficacy Endpoint: Independent (mRS score ≤ 2) functional outcome after 90 days
- Efficacy Endpoint: Early neurological deficit (National Institutes of Health stroke scale) after 24 hours
- Efficacy Endpoint: Health-related quality of life (PROMIS®-10) after 90 days
- Efficacy Endpoint: Cognitive impairment (Montreal Cognitive Assessment) after 90 days
- Safety Endpoint: Any intracranial haemorrhage within 36 hours
- Safety Endpoint: Symptomatic intracranial haemorrhage within 36 hours (mSITS-MOST)
- Safety Endpoint: Fatal intracranial haemorrhage within 30 days
研究者
Senior Physician at the Department of Neurology
Scientific
University Medical Center Hamburg-Eppendorf
研究点 (10)
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