Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS): a Prospective, Randomized, Double Blinded and Multi-center Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)
研究概览
简要总结
Human urinary kallidinogenase (HUK) is a tissue kallikrein extracted from human urine. Under certain conditions, tissue kallikrein can convert kininogen into kallidin and kinins, thereby promoting vascular endothelial function, and exerting anti-inflammatory and antioxidant effects. Preclinical and clinical studies have demonstrated that HUK can salvage the ischemic penumbra and significantly promote the establishment of collateral circulation. Existing research suggests that the combination of HUK with intravenous alteplase significantly improves neurological function in patients with acute ischemic stroke (AIS) without increasing the risk of hemorrhage. However, whether its combination with tenecteplase can further enhance neurological recovery in patients remains unreported. Based on the above discussion, this study aims to investigate the efficacy and safety of combining tenecteplase with HUK in the treatment of AIS.
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
- Quadruple (Participant, Care Provider, Investigator, 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 year;
- •Acute ischemic stroke confirmed by neuroimaging;
- •The time from last known well to treatment is within 4.5 hours;
- •NIHSS ≥ 6 at randomization;
- •Received intravenous tenecteplase (0.25mg/kg);
- •First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
- •Signed informed consent.
排除标准
- •Planed for endovascular treatment;
- •Use of Edaravone Injection, Edaravone Dexborneol Injection, Butylphthalide Injection or Capsules after the onset of the current episode；
- •Prior use of ACE inhibitors within a period less than 5 half-lives before the intended administration of Urinary Kallidinogenase for Injection；
- •Pregnancy；
- •Allergy to the investigational drug(s)；
- •Comorbidity with other serious diseases;
- •Participating in other clinical trials within 3 months;
- •Patients not suitable for the study considered by researcher.
研究组 & 干预措施
experimental group
Urinary Kallidinogenase with 0.15 PNA units dissolved in 100 ml of normal saline, administered via slow intravenous drip over no less than 50 minutes, once daily
干预措施: Human Urinary Kallidinogenase (Drug)
Control group
Urinary Kallidinogenase with placebo dissolved in 100 ml of normal saline, administered via slow intravenous drip over no less than 50 minutes, once daily
干预措施: Human Urinary Kallidinogenase (Drug)
结局指标
主要结局
proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)
时间窗: 90±7 days
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
次要结局
- change in National Institute of Health stroke scale (NIHSS) score(24 (-6/+12) hours)
- symptomatic intracranial hemorrhage (sICH)(24 (-6/+12) hours)
- major systemic bleeding events(24 (-6/+12) hours)
- any bleeding events(24 (-6/+12) hours)
- any intracranial hemorrhage(10±2 days)
- proportion of modified Rankin Scale (mRS) 0-2(90±7 days)
- ordinal distribution of modified Rankin Scale (mRS)(90±7 days)
- change in National Institute of Health stroke scale (NIHSS) score(10±2 days)
- occurrence of early neurological improvement (ENI)(24 (-6/+12) hours)
- new stroke or other vascular event(s)(90±7 days)
- all-cause mortality(90±7 days)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region