Intravenous rhTNK-tPA Bridging With Endovascular Treatment Versus Endovascular Treatment Alone For Stroke Patient With Large Vessel Occlusion: A Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 550
- 试验地点
- 6
- 主要终点
- Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
研究概览
简要总结
The purpose of this trial is to investigate whether intravenous rhTNK-tPA prior to endovascular treatment can improve 90-day functional outcome of stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of symptom onset.
详细描述
The DEVT, SKIP and DIRECT-MT trials showed that endovascular treatment alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. The EXTEND-IA TNK part 1 and part 2 demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before endovascular treatment. However, it is unclear whether intravenous tenecteplase bridging with endovascular treatment is superior to endovascular treatment alone. The purpose of this trial is to investigate whether intravenous rhTNK-tPA bridging with endovascular treatment is better than endovascular treatment alone for stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of onset.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older;
- •Patient with acute ischemic stroke who is eligible for intravenous thrombolysis treatment within 4.5 hours of time last known well;
- •No significant prestroke functional disability: for age <80 years, prestroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;
- •MCA-M1 or -M2, basilar artery, or posterior cerebral artery-P1 occlusion proved by CTA/MRA;
- •EVT is planned by clinical care team;
- •Written informed consent is obtained from patients and/or their legal representatives.
排除标准
- •Intracranial hemorrhage on baseline CT or MR
- •Contraindication to intravenous thrombolytics
- •Already received intravenous thrombolytic after index stroke
- •Known pregnancy, or breastfeeding, or serum beta human chorionic gonadotropin test is positive on admission
- •Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys
- •Current participation in another investigational drug clinical trial
- •Arterial tortuosity and/or other arterial disease that would lead to unstable access platform or prevent the thrombectomy device from reaching the target vessel
- •Patient with a preexisting neurological or psychiatric disease that would confound the outcome assessments
- •Patient with occlusions in two or more vascular territories (e.g. bilateral territories, or anterior and posterior circulation)
- •Mass effect or intracranial neoplasm on baseline CT or MR (except small meningioma)
- •Intracranial arteriovenous malformation or aneurysm on baseline CT or MR angiography
- •Any terminal disease with a life expectancy less than half a year
- •Unlikely to be available for follow-up at 90 days.
研究组 & 干预措施
Conbined treatment group
intravenous tenecteplase bridging with endovascular treatment
干预措施: rhTNK-tPA (Drug)
Conbined treatment group
intravenous tenecteplase bridging with endovascular treatment
干预措施: Endovascular treatment (Other)
Endovascular treatment alone group
endovascular treatment alone
干预措施: Endovascular treatment (Other)
结局指标
主要结局
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
时间窗: 90 days
functional independence
次要结局
- Substantial reperfusion at initial angiogram(within 5 minutes at initial angiogram)
- Successful reperfusion at end-of-procedure angiography(15 minutes after initial angiogram)
- First-pass reperfusion(After artery puncture, but before thrombectomy)
- Modified first-pass reperfusion(After artery puncture, but before thrombectomy)
- National Institutes of Health Stroke Scale (NIHSS) score(5 to 7 days or discharge)
- modified Rankin scale score(90 days)
- Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1)(90 days)
- Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)(90 days)
- Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L)(90 days)
- Any radiologic intracranial hemorrhage within 48 hours(within 48 hours after endovascular treatment)
- Symptomatic intracranial hemorrhage within 48 hours(within 48 hours after endovascular treatment)
- Mortality within 90 days(90 days)
- Procedural-related complications(within 90 days)
- Severe adverse events(within 90 days)
研究者
Zhongming Qiu
Professor
Xinqiao Hospital of Chongqing