Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis (ATTEST 2)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,858
- 试验地点
- 1
- 主要终点
- modified Rankin Scale
研究概览
简要总结
The principle research question is: in patients with acute ischaemic stroke eligible for intravenous (IV) thrombolysis, is tenecteplase superior in efficacy to alteplase, based on functional outcome as assessed by modified Rankin Scale distribution at day 90?
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
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Alteplase - standard care
Alteplase 0.9 mg/kg with 10% of the total dose administered as an initial intravenous bolus and remaining 90% of the total dose administered as an intravenous infusion over 1 hour (maximum dose 90mg).
干预措施: Intravenous recombinant tissue plasminogen activator (rtPA) Alteplase (Drug)
Tenecteplase
Tenecteplase 0.25mg/kg administered as a single rapid intravenous bolus (maximum dose 25mg).
干预措施: Intravenous Tenecteplase (Drug)
结局指标
主要结局
modified Rankin Scale
时间窗: Day 90 (+/- 7)
modified Rankin Scale (mRS) at day 90, determined by the Rankin Focused Assessment (RFA) method using centralised telephone interview, analysed by ordinal distribution ("shift") analysis of the scores in intervention and control groups.
次要结局
- Early major neurological improvement of 8 or more points, or return to the National Institutes of Health Stroke Scale (NIHSS) total score of 0 or 1 at 24 hour(s).(24 hours)
- Health Related Quality of Life (EuroQol five dimensions questionnaire, EQ-5D)(Day 90 (+/- 7))
- Barthel Index score(Day 90 (+/- 7))
- Need for thrombectomy(24 hours)
- Full neurological recovery (modified Rankin Scale 0-1 versus 2-6).(Day 90 (+/- 7))
- Independent recovery (modified Rankin Scale score 0-2 versus 3-6).(Day 90 (+/- 7))