NCT05657457终止3 期
Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT): a Prospective, Randomized, Open-label, Blinded-end Point, Multicenter Trial
General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2023年3月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- proportion of favorable functional outcome
研究概览
简要总结
The potential benefit of intraarterial tenecteplase in acute basilar artery occlusion (BAO) patients with successful reperfusion following endovascular treatment (EVT) has not been studied. The current study aimed to explore the efficacy and safety of intraarterial tenecteplase in acute BAO patients with successful reperfusion after EVT.
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
- •Patients with basilar artery occlusion who received endovascular treatment within 24 hours of estimated time of stroke onset as per BASICS trial definition;
- •National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment;
- •Successful recanalization (mTICI 2b-3) after endovascular treatment;
- •PC-ASPECTS ≥ 6 on CT;
- •Absence of parenchymal hematoma on CT images done in the angio suite immediately after the procedure;
- •Modified Rankin Scale score before stroke onset ≤ 3;
- •Signed informed consent by patient or their legally authorized representative.
排除标准
- •baseline PC ASPECTS < 5 on CT;
- •More than six retrieval attempts in the same vessel;
- •Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
- •Coagulation disorders, systemic hemorrhagic diathesis, thrombocytopenia (<100000/mm3), or INR > 1.7;
- •Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
- •After recanalization, severe and sustained (i.e., > 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication;
- •Patients with contraindication or allergic to any ingredient of drugs in our study
- •Pregnancy, plan to get pregnant or during lactation
- •The estimated life expectancy is less than 6 months due to other serious diseases;
- •Other conditions unsuitable for this clinical study assessed by researcher.
研究组 & 干预措施
TNK group
Experimental
干预措施: Tenecteplase (Drug)
结局指标
主要结局
proportion of favorable functional outcome
时间窗: Day 90
favorable functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 3
次要结局
- change in modified Rankin Score (mRS) compared with premorbid mRS(Day 90)
- change in National Institute of Health stroke scale (NIHSS)(24 (-6/+24) hours)
- proportion of early neurological improvement(24 (-6/+24) hours)
- cerebral edema(24 (-6/+24) hours)
- all-cause mortality(10 days)
- the occurrence rate of composite events of recurrent stroke, cardiovascular or cerebrovascular events(Day 90)
- proportion of sympomatic intracranial hemorrhage(24 (-6/+24) hours)
- proportion of intraparenchymal hemorrhage(24 (-6/+24) hours)
- the proportion of patients with modified Rankin Score (mRS) 0 to 2(Day 90)
- proportion of patients with an improved modified thrombolysis in cerebral infarction score(immediately after intraarterial TNK administration or at the end of endovascular treatment)
- the proportion of patients with modified Rankin Score (mRS) 0 to 1(Day 90)
- ordinal distribution of modified Rankin Score (mRS)(Day 90)
- change in the cerebral circulation time(immediately after tenecteplase)
- the percentage of severe adverse events(24 (-6/+24) hours)
- the number of tenecteplase infusions interrupted due to suspected active bleeding(during endovascular treatment (up to 2 hours))
研究者
Hui-Sheng Chen
Head of Neurology
General Hospital of Shenyang Military Region
研究点 (1)
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