Intravenous Tenecteplase for Acute Ischemic Stroke With Unknown Time of Onset Under Non-Contrast CT Selection: A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Excellent outcome
研究概览
简要总结
The benefit of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, e.g. wake-up stroke, remains uncertain. This randomized study aims to assess the efficacy and safety of intravenous tenecteplase following non-contrast CT screening for acute ischemic stroke with unknown time of onset.
详细描述
UTOPIA is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded endpoint (PROBE) trial that aims to assess the efficacy and safety of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, selected by non-contrast CT. The primary outcome is excellent outcome, as defined by a score of 0 or 1 on modified Rankin Scale (mRS) at 90 days.
Participants randomized to the intervention group will receive intravenous tenecteplase at 0.25 mg/kg with a maximum dose of 25 mg and standard medical treatment, and those randomized to the control group will receive standard medical treatment only, without intravenous thrombolysis.
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)
盲法说明
The study drug will be open-label, but outcome assessors remain unaware of group allocation.
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
- •Age ≥ 18 years old.
- •Clinical diagnosis of acute ischemic stroke.
- •Unknown time of stroke onset (e.g., stroke symptom recognized on awakening) but last-known normal time >4.5 hours.
- •Time from stroke symptom recognition (e.g., awakening) to randomization within 3 hours.
- •National Institutes of Health Stroke Scale (NIHSS) score of 6-25 (both inclusive).
- •Pre-stroke modified Rankin Scale (mRS) score of 0-
- •Written informed consent from patients or their legally authorized representatives.
排除标准
- •Intracranial hemorrhage confirmed by skull CT, or history of intracranial hemorrhage.
- •Planned endovascular treatment.
- •Rapid neurological improvement with NIHSS <6 at randomization.
- •Allergy to tenecteplase.
- •Use of vitamin K antagonist with INR >1.7, use of heparin or low molecular heparin in the past 24 hours, or use of direct oral anticoagulants in the past 48 hours.
- •Hypodensity on non-contrast CT >1/3 middle cerebral artery territory.
- •Severe traumatic brain injury or other major trauma in the past 3 months.
- •Intracranial neoplasm, arteriovenous malformation, or aneurysm (≥10mm).
- •Intracranial surgery, intraspinal surgery, or other major surgery in the past 3 months.
- •Gastrointestinal or urinary tract hemorrhage in the past 3 weeks.
- •Active internal bleeding.
- •Aortic dissection.
- •Infective endocarditis.
- •Platelet count <100×10^9/L.
- •Women who are pregnant or breastfeeding.
- •Blood glucose <50 or >400 mg/dL (<2.78 or >22.2 mmol/L).
- •Systolic blood presure >185 mmHg or diastolic blood presure >110 mmHg refractory to treatment.
- •Life expectancy <3 months.
- •Participating in other trials.
- •Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
研究组 & 干预措施
Tenecteplase group
Intravenous tenecteplase thrombolysis
干预措施: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) (Drug)
Tenecteplase group
Intravenous tenecteplase thrombolysis
干预措施: Standard medical treatment (Other)
Control group
Standard Medical Treatment
干预措施: Standard medical treatment (Other)
结局指标
主要结局
Excellent outcome
时间窗: 90 (±14) days
The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days
次要结局
- Level of disability(90 (±14) days)
- Functional independence(90 (±14) days)
- Early neurological improvement(24 (±12) hours)
- Change in stroke severity(7 (±1) days or at discharge)
- Quality of life measured by EQ-5D-5L(90 (±14) days)