NCT05657444已完成3 期
Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II): a Prospective, Randomized, Adaptive Enrichment, Open-label, Blinded End Point, Multi-center Study
General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 380 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
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- proportion of favorable outcome
研究概览
简要总结
A recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO).
The study aimed to determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients.
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;
- •Stroke patient with large vessel occlusion (internal carotid artery, M1 or M2 of middle cerebral artery, basilar artery, or intracranial segment of vertebral artery) who meets criteria for endovascular treatment within 24 hours of stroke onset;
- •The modified Rankin Scale (mRS) score before onset ≤ 2;
- •ASPECTS 6 or greater on CT
- •Signed informed consent.
排除标准
- •hemorrhagic stroke;
- •Tandem occlusion;
- •Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<100000/mm3);
- •Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), elevated serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
- •Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
- •Patients with contraindication or allergic to any ingredient of drugs in our study;
- •Pregnancy, or plan to get pregnant or during active lactation;
- •Suspected septic embolus or infective endocarditis
- •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 favorable outcome
时间窗: Day 90
Favorable outcome is defined as modified Rankin Scale (mRS) score of 0-2
次要结局
- change in National Institute of Health stroke scale (NIHSS)(24 (-6/+24) hours)
- proportion of excellent outcome(Day 90)
- proportion of successful reperfusion after the first-pass or final pass of endovascular treatment(immediately after the first-pass or final pass of endovascular treatment)
- Distribution of modified Rankin Scale (mRS)(Day 90)
- Change in cerebral circulation time after intervention(immediately after endovascular treatment)
- occurrence rate of symptomatic intracranial hemorrhage(24 (-6/+24) hours)
- occurrence rate of the distal emboli after first pass(immediately after first pass)
- occurrence rate of early neurological improvement(24 (-6/+24) hours)
- cerebral edema(24 (-6/+24) hours)
- occurrence rate of the composite events of nonfatal stroke, nonfatal myocardial infarction, and other cardiovascular events(Day 90)
- percentage of severe adverse events(24 (-6/+24) hours)
- occurrence rate of parenchymal hemorrhage(24 (-6/+24) hours)
- death due to all causes(Day 7 or during hospitalization)
- occurrence rate of extracranial hemorrhage(24 (-6/+24) hours)
研究者
Hui-Sheng Chen
Head of Neurology
General Hospital of Shenyang Military Region
研究点 (1)
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