Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients (3T Stroke-Ⅲ)
Acute Ischemic Stroke
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring TNK-tPA, rt-PA, Acute stroke, phase Ⅲ trial
Eligibility Criteria
Inclusion Criteria: 18≤Age≤80 years old; The clinical diagnosis was Acute ischemic stroke 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"; MRS before onset was ≤1 points; Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points; Informed consent from the patient or surrogate. Exclusion Criteria: Intracranial hemorrhage identified by CT or MRI (CMBs detected by SWI is not counted); Massive anterior cerebral infarction identified by CT or MRI (ASPECT < 6 or lesions larger than one third of the territory of the middle cerebral artery or with a volume larger than 70mL) Patients planning to receive endovascular therapy A history of severe CNS damage (such as aneurysm or arteriovenous malformation, craniocerebral trauma, intracranial or spinal cord surgery) Onset with seizures, and the paralysis was suspected to be related to Todd paralysis. Administration of heparin within 48 hours preceding the onset of stroke with a baseline APTT exceeding the upper limit of the normal range. Oral anticoagulant (such as warfarin) treatment with baseline INR>1.7 or PT>15 s; Administration of thrombin inhibitors or factor Xa inhibitors within 48 hours preceding the onset of stroke with abnormal coagulation parameters or platelet count; BP couldn't be controlled with aggressive treatment. Uncontrolled hypertension was defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, measured for three times every 10 minutes. Platelet count of less than 100×109/ L; Blood glucose <50 mg/dl (<2.8 mmol/L) or >400 mg/dl (22.22 mmol/L); History of intracranial hemorrhage or active hemorrhagic disease. (Such as gastrointestinal, urinary tract or retinal bleeding) Tumors with an increased risk of bleeding. Prolonged or traumatic cardiopulmonary resuscitation (>2 min), delivery within the last 10 days or recent puncture of non-compression vessels such as subclavian vein or jugular vein Acute pancreatitis or severe liver disease, including liver failure, cirrhosis, portal hypertension, esophageal varicose veins, and active hepatitis; Aortic arch dissection; Major surgery or severe trauma in the past 2 weeks; Subjects had serious, fatal, or disabling disease with an expected survival of less than 3 months; Unable to complete neurological assessment and follow-up visits because of dementia or mental illness; Pregnant women, lactating women, or have positive pregnancy test; Allergy to tenecteplase or alteplase or their components; Participation in other clinical trials within 3 months prior to screening; Unsuitable to involve in this study or would result in increased risk, as judged by the investigators.
Sites / Locations
- Xuancheng People's Hospital
- Beijing Tiantan Hospital, Capital Medical University Beijing
- Xuanwu Hospital Capital Medical University
- Three Gorges Hospital Affiliated to Chongqing University
- Quanzhou First Hospital
- Lanzhou University First Hospital
- The Third People's Hospital of Huizhou
- Yuebei People's Hospital
- The First People's Hospital of Yulin
- Handan Central Hospital
- Hengshui people's Hospital (Harrison International Peace Hospital)Recruiting
- Tangshan Workers' Hospital
- Daqing Oilfield General Hospital
- Daqing People's Hospital
- Anyang People's Hospital
- Jiaozuo People's Hospital
- Nanyang South Stone Hospital
- Pingmei Shenma medical group general hospital
- Xinxiang Central Hospital
- Zhoukou Downtown Hospital
- The First People's Hospital of Jingzhou
- Baogang Hospital of Inner Monglia
- Baotou Central Hospital
- Keshenketengqi Mongolian Medicine HospitalRecruiting
- The Second Affiliated Hospital of Suzhou Medical University
- Taizhou People's Hospital
- Xuzhou Central Hospital
- Xuzhou Mining Group General Hospital
- The Affiliated Hospital of Xuhzou Meidcal University
- The First Hospital of Jilin University
- Jilin Guowen Hospital
- Siping Central People's Hospital
- Tonghua Central Hospital
- Meihekou Central Hospital
- Beipiao Central HospitalRecruiting
- Dalian Central Hospital
- Fushun Mining Bureau General Hospital
- Liaoning Health Industry Group Fuxin Mine General Hospital
- The First Affiliated Hospital of Jinzhou Medical University
- Affiliated Central Hospital of Shenyang Medical College
- Air Force Hospital of Northern War Zone,PLA
- General Hospital of Northern War Zone,PLA
- The First Affiliated Hospital of China Medical University
- The First People's Hospital of Shenyang
- General Hospital of Ningxia Medical University Cardio-cerebral Vascular Disease Hospital
- The First People's Hospital of Yinchuan
- Dezhou Hospital of Shandong University Qilu Hospital (Dezhou People's Hospital)
- Jinan People's Hospital
- Qilu Hospital of Shandong University
- Liaocheng People's Hospital
- Linyi Hospital of Traditional Chinese Medicine
- Linyi People's Hospital
- The First People's Hospital of Tancheng CountyRecruiting
- Taian Central Hospital (Tai 'an Central Hospital of Qingdao University, Tai 'an Medical and Nursing Center)
- Tengzhou Central Hospital
- Weifang Hospital of Traditional Chinese Medicine
- Yantai Yuhangding Hospital
- Sinopharm Coal Mine General Hospital
- Linfen Central HospitalRecruiting
- Linfen People's Hospital
- Shanxi Cardiovascular Disease Hospital
- Dazhu County People's Hospital
- Mianyang Central Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Alteplase
Tenecteplase
Patients will receive intravenous Alteplase at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour.
Patients will receive intravenous Tenecteplase, 0.25mg/kg, maximum 25mg, administered as a bolus over 5~10 seconds