Intravenous Tenecteplase Before Interhospital Transfer for Thrombectomy in Acute Basilar Artery Occlusion at 4.5 to 24 Hours
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 506
- 试验地点
- 1
- 主要终点
- Dichotomized mRS of 0-2 vs. 3-6
研究概览
简要总结
This study is designed to investigate the efficacy and safety of intravenous tenecteplase before interhospital transfer from a non-endovascular capable center(nECC) to an endovascular capable center (ECC) for thrombectomy in patients with acute ischemic stroke (AIS) caused by neuroimaging-confirmed acute basilar artery occlusion (BAO) between 4.5-24 hours of symptom onset.
详细描述
This is a multicenter, prospective, open-label, blinded endpoint (PROBE), randomized controlled trial in patients with acute ischemic stroke due to BAO first presenting to a nECC and intending to undertake thrombectomy in an ECC.
Patients will be required to have occlusion of the basilar artery on baseline computed tomography angiography (CTA)/magnetic resonance angiography (MRA) at the nECC. Patients will be randomized to either intravenous tenecteplase (0.25mg/kg, maximum 25mg)or not before interhospital transfer.
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
- •1. Age ≥18 years;
- •Patients presenting with posterior circulation ischemic stroke symptoms due to BAO;
- •BAO confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA);
- •Time from symptom onset to randomization within 4.5-24 hours, stroke onset is defined as the time the patient was last known to be well (including wake-up stroke and unwitnessed stroke);
- •Baseline National Institute of Health Stroke Scale (NIHSS) score obtained prior to randomization ≥6;
- •Functionally independent (modified Rankin Scale [mRS] 0-2) prior to stroke onset; 7 Intended to transfer to CSCs for thrombectomy
- •Written informed consent from patients or legally responsible representatives
排除标准
- •1 Posterior Circulation Acute Stroke Prognosis Early CT score (PC-ASPECTS) < 6 on computed tomography (CT)/CTA-Source Images/MRI with diffusion-weighted imaging (DWI) 2 CT/MR shows evidence of intracranial hemorrhage and tumor (except small meningioma) 3 Complete cerebellar infarct on CT/MRI with significant mass effect and compression of the 4th ventricle 4 Bilateral extensive brainstem infarction on CT/MRI 5 Simultaneous occlusion of both anterior and posterior circulation confirmed by CTA/MRA/DSA (patients with a history of occlusion of anterior circulation can be included) 6 Treatment with a thrombolytic within the last 72 hours or intention to receive intravenous thrombolysis 7 Known hypersensitivity or allergy to any ingredients of Tenecteplase 8 Any other contra-indication for intravenous thrombolysis except for the time criteria 9 Known hereditary or acquired hemorrhagic diathesis 10 Impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, international normalized ratio (INR) >1.7 or prothrombin time >15s; if use of any direct oral anticoagulant within the last 48 hours; if use of heparin/heparinoid within the last 24 hours 11 Ischemic stroke or myocardial infarction in previous 3 months 12 Previous intracranial hemorrhage, active internal bleeding (gastrointestinal or urinary tract hemorrhage) in previous 3 months 13 Severe, uncontrolled hypertension (systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg) 14 Baseline blood glucose <50mg/dl or >400mg/dl 15 Baseline platelet count <100,000/μL 16 Undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency with glomerular filtration rate <30mL/min or serum creatinine >220mmol/L (2.5mg/dL) 17 Known severe, life-threatening allergy (more severe than skin rash) to contrast agents 18 Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery 19 Known diagnosis or clinical suspicion of cerebral vasculitis 20 Known diagnosis or clinical suspicion of endocarditis 21 Pregnancy or lactating; 22 Other serious, advanced or terminal illness with life expectancy less than 6 months 23 Current participation in any investigational study that may confound outcome assessment of the study 24 Any condition that, in the judgement of the investigator, is inappropriate for participation in the trial or could impose hazards to the patient (e.g. inability to understand and/or follow the study procedures and/or follow-up due to mental disorders, cognitive or emotional disorders)
研究组 & 干预措施
Interventional group
Patients will receive intravenous Tenecteplase 0.25 mg/kg body-weight up to a maximum of 25mg before the transfer. A single bolus dose should be administered over 5-10 seconds based on patient weight. Transfer to ECCs for thrombectomy should be initiated immediately after Tenecteplase administration.
干预措施: Tenecteplase thrombolysis (Drug)
结局指标
主要结局
Dichotomized mRS of 0-2 vs. 3-6
时间窗: 90±7 days
Dichotomized mRS of 0-2 vs. 3-6 at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
次要结局
- Ordinal mRS score(90 (±7) days)
- Dichotomized mRS of 0-1 vs. 2-6(90 (±7) days)
- Dichotomized mRS of 0-3 vs. 4-6(90 (±7) days)
- Early dramatic clinical response rate(24 (±12) hours)
- Arterial recanalization during interhospital transfer(At ECC before thrombectomy)
- Successful reperfusion(At end-of-procedure angiography)
- First pass reperfusion(Immediately after the thrombectomy)
- Arterial recanalization(24(±12) hours)
- EQ-5D-5L(90 (±7) days)