Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset: A Multicenter, Prospective, Randomized, Open-Label, Blinded Endpoint Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 406
- 试验地点
- 1
- 主要终点
- Proportion of patients with modified Rankin Scale (mRS) score 0-1 at 90 ±14 days;
研究概览
简要总结
This study aims to evaluate the efficacy and safety of tenecteplase (TNK) intravenous thrombolysis within the extended time window (4.5 to 24 hours) in patients with acute posterior circulation ischemic stroke.
详细描述
This multicenter, prospective, randomized, controlled trial assesses the efficacy and safety of intravenous tenecteplase for acute posterior-circulation ischemic stroke treated 4.5-24 hours after onset. Participants with imaging-confirmed stroke will be randomly assigned 1:1 to receive either tenecteplase or standard medical therapy. Eligible patients must present within 4.5-24 hours from symptom onset, defined as the midpoint between last known normal and first observed neurological deficit. All participants will undergo telephone follow-up at 3 months and 1 year, with the modified Rankin Scale as the primary outcome measure.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Meeting at least one of the following criteria: acute posterior circulation ischemic stroke confirmed by MRI; symptomatic stenosis or occlusion of a posterior circulation large vessel on vascular imaging (CTA/MRA/DSA); perfusion imaging demonstrating clinically relevant hypoperfusion in the posterior circulation territory.
- •Onset time between 4.5-24 hours (for wake-up stroke or unwitnessed stroke, onset time is defined as the midpoint between last known well and symptom detection).
- •NIHSS score>
- •PC-ASPECTS ≥7 (if discrepancy exists between DWI and CT findings, CT assessment takes precedence).
- •Pre-stroke mRS ≤
- •Signed informed consent by the patient or legally authorized representative.
排除标准
- •Contraindication to tenecteplase or its components.
- •Planing to receive endovascular therapy with thrombectomy, angioplasty or stenting whin 3 months.
- •Acute anterior circulation infarction confirmed by MRI, anterior circulation large vessel occlusion on vascular imaging (CTA/MRA/DSA), or anterior circulation hypoperfusion on perfusion imaging.
- •History of intracranial hemorrhage.
- •Stroke, myocardial infarction, severe traumatic brain injury, or intracranial/spinal surgery within the preceding 3 months.
- •Intracranial tumor, arteriovenous malformation (AVM), or giant aneurysm.
- •Active internal bleeding, major surgery, trauma, gastrointestinal/urinary tract bleeding within 3 weeks.
- •Non-compressible arterial puncture within 1 week.
- •Suspected aortic dissection.
- •Clinically significant bleeding or coagulopathy, including: Warfarin use with INR >1.7 or PT >15 s; Low-molecular-weight heparin within 24 hours; Direct oral anticoagulants within 48 hours; Laboratory abnormalities (e.g., APTT >40 s).
- •Platelet dysfunction or platelet count <100×10⁹/L.
- •Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg unresponsive to antihypertensive therapy).
- •Uncontrolled hypoglycemia/hyperglycemia (<50 mg/dL [2.8 mmol/L] or >400 mg/dL [22.2 mmol/L]).
- •Pregnancy or lactation.
- •A life expectancy of less than three months.
- •Participation in other clinical trials within 3 months or ongoing trial enrollment.
- •Inability to follow up (e.g., no fixed residence, overseas patients).
- •Patient deemed unsuitable for the trial by site investigator.
研究组 & 干预措施
standard medical management
standard medical management
干预措施: standard medical management (Drug)
TNK plus standard medical treatment
Patients in the TNK treatment group will receive TNK intravenous thrombolysis and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg.
干预措施: TNK plus standard medical treatment (Drug)
结局指标
主要结局
Proportion of patients with modified Rankin Scale (mRS) score 0-1 at 90 ±14 days;
时间窗: 90 ±14 days
次要结局
- Proportion of patients with mRS score 0-2 at 90 ±14 days;(90 ±14 days)
- EQ-5D-5L questionnaire score at 90 ±14 days;(90 ±14 days)
- Overall incidence of serious adverse events(90 ±14 days)
- Proportion of patients with mRS score 0-3 at 90 ±14 days;(90 ±14 days)
- Change in NIHSS score at 24-36 hours post-treatment(24 hours post-treatment)
- 5)Change in NIHSS score at 5-7 days post-treatment;(5-7 days post-treatment)
- 1)Symptomatic intracranial hemorrhage within 36 hours (Heidelberg criteria)(24-36 hours after treatment)
- Any intracranial hemorrhage within 36 hours (Heidelberg criteria)(24-36 hours after treatment)
- Ordinal distribution of mRS score at 90 ±14 days;(90 ±14 days)
- Mortality rate at 90 ±14 days(90 ±14 days)
- Barthel Index score at 90 ±14 days;(90 ±14 days)
研究者
Wei Hu
Professor
The First Affiliated Hospital of University of Science and Technology of China