Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion: a Multi-center, Prospective, Randomized, Open-label, Blinded Endpoint (PROBE), Phase 3 Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 391
- 试验地点
- 21
- 主要终点
- The modified Rankin Scale (mRS) score 0 to 2 at 90 days
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of endovascular treatment with or without preceding intravenous Tenecteplase in patients with late-window (4.5-24 hours of symptom onset) acute ischemic stroke due to middle cerebral artery (MCA) M1 or proximal M2 occlusion.
详细描述
After being informed about the study and potential risks, patients who meet the inclusion criteria will be randomized to endovascular treatment with preceding intravenous Tenecteplase (0.25mg/kg, maximum 25mg) or without preceding intravenous Tenecteplase in a 1:1 ratio. Written informed consent will be needed.
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
blinded-endpoint
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
IVT with Tenecteplase+EVT
Tenecteplase 0.25mg/kg: 1-2 vials (1.0×107 IU/16 mg per vial) Each vial of Tenecteplase is reconstituted with 3 ml sterile water for injection and adjusted to a concentration of 5.33 mg/ml. The total amount of drug will be calculated according to the subject's actual body weight and the required drug volume will be measured. The maximum dose should not exceed 25mg. Tenecteplase should be given as a single, intravenous bolus (drug administered over 5-10 seconds).
Endovascular treatment (EVT) should be performed as soon as possible after Tenecteplase administration.
干预措施: Tenecteplase (Drug)
Direct EVT
During the study period, NMPA-approved stents are permitted. EVT included thrombectomy with stent retrievers, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team.
干预措施: direct EVT (Device)
结局指标
主要结局
The modified Rankin Scale (mRS) score 0 to 2 at 90 days
时间窗: 90 days
The proportion of the modified Rankin Scale (mRS) score 0 to 2 at 90 days. Scores on the mRS range from 0 to 6, with higher scores indicating greater disability.
次要结局
- Ordinal shift analysis of mRS at 90 days (not combined mRS 5 and 6)(90 days)
- mRS 0-1 at 90 days(90 days)
- mRS 0-3 at 90 days(90 days)
- mRS 5-6 at 90 days(90 days)
- NIHSS≤1 or a decrease of 8 points or more from baseline at 72h after randomization(72 hours)
- Change in stroke severity (NIHSS score) at 7 days after randomization from baseline(7 days)
- Successful reperfusion prior to endovascular treatment by DSA (eTICI 2b50-3)(0 hours (at treatment time))
- Complete recanalization according to CTA or MRA performed 24 hours after randomization(24 hours)
- Good reperfusion at 24h after randomization(24 hours)
研究者
Yunyun Xiong
Professor
Beijing Tiantan Hospital