Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ
- Registration Number
- NCT04797013
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief Summary
A Phase Ⅲ, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours
- Detailed Description
To test the hypothesis that rhTNK-tPA is non-inferior to alteplase in thrombolysis treatment when administered within 4.5 hours of ischemic stroke onset.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1430
- Age ≥18 years old, no gender limitation;
- The time from onset to treatment was < 4.5h;The time at which symptoms begin is defined as "the time at which they finally appear normal";
- The clinical diagnosis was ischemic stroke (the diagnosis followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);
- MRS before onset was 0-1 points
- Baseline NIHSS 5-25(both included);
- Informed consent from the patient or surrogate.
- Intended to proceed endovascular treatment;
- NIHSS consciousness score >2;
- Allergy to tenecteplase or alteplase;
- Past history of intracranial hemorrhage ;
- A history of severe head trauma or stroke within 3 months;
- A history of intracranial or spinal surgery within 3 months;
- A history of gastrointestinal or urinary bleeding within 3 weeks;
- 2 weeks of major surgery;
- Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;
- Intracranial tumors (except neuroectodermal tumors, such as meningiomas), large intracranial aneurysms;
- Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
- Active visceral bleeding;
- Aortic arch dissection was found;
- After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
- Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;
- Blood glucose <2.8 mmol/L or >22.22 mmol/L;
- Oral warfarin anticoagulant with INR>1.7 or PT>15 s;
- Heparin treatment was received within 24 h;
- Thrombin inhibitors or factor Xa inhibitors were used within 48 h;
- Head CT or MRI showed a large infarction (infarcted area > 1/3 of the middle cerebral artery);
- Subjects who are unable or unwilling to cooperate due to hemiplegia (Todd's palsy) after epileptic seizure or other neurological/psychiatric disorders;
- Pregnant women, lactating women, or subjects who do not agree to use effective contraception during the trial;
- Participation in other clinical trials within 3 months prior to screening;
- Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rhTNK-tPA (0.25mg/kg) rhTNK-tPA rhTNK-tPA (0.25mg/kg) is given as a single, intravenous bolus (within 5-10 seconds) immediately upon randomization. Maximum dose 25mg. rt-PA (0.9mg/kg) rt-PA 10% dose of rt-PA (0.9 mg/kg) is given as bolus and the remainder in 1 hour. Maximum dose 90mg.
- Primary Outcome Measures
Name Time Method Excellent functional outcome 90 days Proportion of subjects with mRS(0-1) at 90 days.
- Secondary Outcome Measures
Name Time Method National Institutes of Health Stroke Scale (NIHSS) 24 hours，day7 Proportion of subjects with NIHSS score ≥ 4 improved compared with baseline at 24 or with NIHSS 0-1 at 24 hours and 7 days.
Barthel (BI) 90 days Global function of daily living defined as BI ≥ 95 at 90 days.
Good functional outcome 90 days Proportion of subjects with mRS(0-2) at 90 days.
Modified Rankin Scale(mRS) 90 days Ordinal distribution of mRS at 90 days.
EQ-5D 90 days Quality of life measured by EQ-5D scale.
Trial Locations
- Locations (61)
The first affiliated hospital of ustc
🇨🇳Hefei, Anhui, China
The people's hospltal of xuancheng city
🇨🇳Xuancheng, Anhui, China
Beijing luhe hospital capital medical university
🇨🇳Beijing, Beijing, China
Guizhou provincial people's hospital
🇨🇳Guiyang, Guizhou, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
🇨🇳Guangdong, Guangdong, China
The first hospital of hebei medical university
🇨🇳Shijiazhuang, Hebei, China
The first affiliated hospital of hebei north university
🇨🇳Zhangjiakou, Hebei, China
Tangshan Workers ' Hospital
🇨🇳Tangshan, Hebei, China
Daqing Oilfield General Hospital
🇨🇳Daqing, Heilongjiang, China
Nanyang Nanshi Hospital
🇨🇳Nanyang, Henan, China
Nayang second general hospital
🇨🇳Nanyang, Henan, China
Xinxiang first people's hospital
🇨🇳Xinxiang, Henan, China
The central hospital of wuhan
🇨🇳Wuhan, Hunan, China
Kashkten Mongolian Medicine Hospital
🇨🇳Chifeng, Inner Mongolia, China
Inner Mongolia People'S Hospital
🇨🇳Hohhot, Inner Mongolia, China
Huai an second people's hospital
🇨🇳Huaian, Jiangsu, China
Jiangsu taizhou people's hopital
🇨🇳Taizhou, Jiangsu, China
General Hospital of Xuzhou Mining Group
🇨🇳Xuzhou, Jiangsu, China
Xuzhou central hospital
🇨🇳Xuzhou, Jiangsu, China
Third Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Jilin neuropsychiaric hospital
🇨🇳Siping, Jilin, China
Tonghua Central Hospital
🇨🇳Tonghua, Jilin, China
Meihekou Central Hospital
🇨🇳Tonghua, Jilin, China
The Firet Affiliated Hospital of Jinzhou Medical University
🇨🇳Jinzhou, Liaoning, China
Central hospital affiliated to shenyang medical college
🇨🇳Shenyang, Liaoning, China
The first hospital of china medical university
🇨🇳Shenyang, Liaoning, China
Tengzhou Central People's Hospital
🇨🇳Tengzhou, Shandong, China
General Hospital of Northern War Zone, PLA
🇨🇳Shenyang, Liaoning, China
Linyi City People Hospital
🇨🇳Linyi, Shandong, China
Yantai Yuhuangding Hosopital
🇨🇳Yantai, Shandong, China
Huashan Hospital Affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Heping hospital affiliated to changzhi medical college
🇨🇳Changzhi, Shanxi, China
Linfen people's hospital
🇨🇳Linfen, Shanxi, China
Xianyang Hospital of Yan ' an University
🇨🇳Xianyang, Shanxi, China
The fifth people's s hospital of datong
🇨🇳Datong, Shanxi, China
Linfen central hospital
🇨🇳Linfen, Shanxi, China
Mianyang central hospital
🇨🇳Mianyang, Sichuan, China
Shanxi Cardiovascular Hospital
🇨🇳Taiyuan, Shanxi, China
Shanxi provincial prople's hospital
🇨🇳Taiyuan, Taiyuan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Lishui Central Hospital
🇨🇳Lishui, Zhejiang, China
Taizhou Enze Medical Center ( Group )
🇨🇳Taizhou, Zhejiang, China
Wenzhou Central Hospital
🇨🇳Wenzhou, Zhejiang, China
Chongqing Three Gorges Central Hospital
🇨🇳Chongqing, Chongqing, China
Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The first hospital of lanzhou university
🇨🇳Lanzhou, Gansu, China
Yue bei people's hospital
🇨🇳Shaoguan, Guangdong, China
Affiliated hospital of chengde medical university
🇨🇳Chengde, Hebei, China
the Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The 2ad affiliated hospital of harbin medical university
🇨🇳Haerbin, Heilongjiang, China
Second People's Hospital of Jiaozuo City
🇨🇳Jiaozuo, Henan, China
Nanyang central hospital
🇨🇳Nanyang, Henan, China
Pingmei Shenma Medical Group General Hospital
🇨🇳Pingdingshan, Henan, China
Xinyang central hospital
🇨🇳Xinyang, Henan, China
The first affiliated hospital of zhengzhou university
🇨🇳Zhengzhou, Henan, China
Inner Mongolia Baotou Hospita
🇨🇳Baotou, Inner Mongolia, China
Affiliated Hospital of Chifeng University
🇨🇳Chifeng, Inner Mongolia, China
General Hospital of Chinese Medicine and Coal
🇨🇳Datong, Shanxi, China
The First People'S Hospital of Shenyang
🇨🇳Shenyang, Liaoning, China
First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China