NCT05657470已完成2 期
Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK): a Prospective, Randomized, Open-label, Blinded End Point, and Multicenter Trial
General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年3月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- proportion of patients with successful Medium vessel occlusion (MeVO) recanalization
研究概览
简要总结
The best reperfusion strategy for medium-sized vessel occlusion (MeVO) is not well established. Given the proven treatment effect of intra-arterial thrombolysis in patients with large vessel occlusion (LVO), the investigators hypothesized that intra-arterial tenecteplase (TNK) could increase the recanalization rate of MeVO and thus improve clinical outcome. The current study aimed to explore the safety and efficacy of intra-arterial TNK in patients with MeVO.
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
- •Age ≥18 years;
- •Medium vessel occlusion (MeVO), referring to M2-3 of MCA; A1-3 of ACA; P1-3 of PCA; PICA, AICA or SCA (including primary, distal embolism in the same region after thrombectomy or concurrent embolism in other regions).
- •Primary MeVO as detected by the first DSA examination or secondary MeVO after mechanical thrombectomy for large vessel occlusion;
- •MeVO causes neurological deficits in motor strength, language, vision etc;
- •Endovascular mechanical thrombectomy cannot be performed as assessed by the investigator;
- •Absence of parenchymal hematoma on CT images performed in the angio suite.
- •Within 24 hours from symptom onset;
- •Signed informed consent by patient or patient's legally authorized representative.
排除标准
- •Patients with completed infarction in the territory of the MeVO on non-contrast CT;
- •Patients with intracranial hemorrhage;
- •Coagulation disorders, tendency for systemic hemorrhagic, thrombocytopenia (<100,000/mm3);
- •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 mechanical thrombectomy, severe and sustained (> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg);
- •Patients with contraindication or allergy to any ingredient of study medication;
- •Pregnancy, plan to get pregnant or active lactation;
- •The estimated life expectancy is less than 6 months due to other serious diseases;
- •Other conditions unsuitable for this clinical study as 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 patients with successful Medium vessel occlusion (MeVO) recanalization
时间窗: immediately after finishing intra-arterial tenecteplase
successful MeVO recanalization is defined as the expanded treatment in cerebral ischemia (eTICI) score 2b67-3 in the territory of the target occluded MeVO artery
次要结局
- incidence of early neurological improvement(24 (-6/+24) hours)
- proportion of modified Rankin Scale (mRS) 0-1(Day 90)
- proportion of symptomatic intracranial hemorrhage(24 (-6/+24) hours)
- proportion of modified Rankin Scale (mRS) 0-2(Day 90)
- distribution of modified Rankin Scale (mRS)(Day 90)
- recurrent stroke, cardiovascular events, other vascular events and death(90 days)
- Changes in National Institute of Health stroke scale (NIHSS)(24 (-6/+24) hours)
- rate of visual recovery in patients with posterior cerebral artery occlusion(7 days or at hospital discharge)
- proportion of parenchymal hematoma type 1 and 2(24 (-6/+24) hours)
- all serious adverse events(24 (-6/+24) hours)
- all-cause death(7 days)
研究者
Hui-Sheng Chen
Head of Neurology
General Hospital of Shenyang Military Region
研究点 (1)
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