Extended Time Window Intravenous Tenecteplase Thrombolysis Registry for Acute Ischemic Stroke (EXTEND-TNK Registry)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- The modified Rankin Scale score (mRS) 0-1
研究概览
简要总结
The EXTEND-TNK Registry is a prospective, multicenter, observational cohort study designed to evaluate the effectiveness and safety of intravenous tenecteplase administered beyond 4.5 hours after last known well in patients with acute ischemic stroke (AIS) in routine clinical practice across China.
详细描述
This prospective, multicenter, observational cohort registry enrolls adult patients (≥18 years) with acute ischemic stroke who receive intravenous tenecteplase more than 4.5 hours after last known well. Patient selection, imaging strategies, thrombolytic dosing, and concomitant therapies are determined by treating physicians according to local clinical practice, without study-mandated intervention.
The primary outcome is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-1 at 90±14 days. This registry describes real-world patient characteristics, treatment patterns, and outcomes of extended time window intravenous tenecteplase, and explores factors associated with clinical outcomes to inform patient selection and future clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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;
- •2. Clinical diagnosed of acute ischemic stroke;
- •3. Time from last known well (LKW) to initiation of intravenous thrombolysis > 4.5 hours (including wake-up stroke and unwitnessed stroke);
- •4. Received intravenous tenecteplase;
- •5. Provided written informed consent.
排除标准
- •1. Any condition judged by the investigator to make the participant unsuitable for study participation or follow-up (e.g., psychiatric disorders, cognitive impairment, or emotional disturbances).
研究组 & 干预措施
Extended time window intravenous tenecteplase
干预措施: Tenecteplase (Drug)
结局指标
主要结局
The modified Rankin Scale score (mRS) 0-1
时间窗: 90±14 days
The proportion of mRS score 0-1 or a return to baseline if the pre-stroke mRS score ≥2 at 90±14 days. The modified Rankin Scale is a 7-point ordinal scale ranging from 0 to 6, with higher scores indicating greater disability (0 = no symptoms; 6 = death).
次要结局
- Level of disability(90±14 days)
- The modified Rankin Scale score (mRS) 0-2(90±14 days)
- The modified Rankin Scale score (mRS) 0-3(90±14 days)
- Change in neurologic deficit (NIHSS score) at 24 hours(24±12 hours)
- Change in neurologic deficit (NIHSS score) at 7 days or discharge(7±1 days)
- The modified Rankin Scale score (mRS) 0-1 at 1 year(1 year ± 60 days)
- Stroke recurrence within 90 days(90±14 days)
- Stroke recurrence within 1 year(1 year ± 60 days)