The trial is prospective, block randomized, open-label, blinded endpoint (PROBE) design. Patients with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of stroke onset will be randomized 1:1:1 to 0.25mg/kg or 0.40mg/kg intravenous tenecteplase or 0.9 mg/kg alteplase before all participants undergo endovascular thrombectomy.
The study will be a multi-center, prospective, randomized, open- label, blinded endpoint (PROBE), controlled phase 2 trial (3 arm with 1:1:1 randomization) in ischemic stroke patients. Imagine is performed with CT or MRI acutely with imaging follow-up at 24-30 hours. The sample size is 225.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
225
Alteplase 0.9mg/kg are being used.
Tenecteplase 0.25mg/kg are being used.
Tenecteplase 0.4mg/kg are being used.
Modified Rankin Scale(mRS)
Proportion of subjects with mRS scores of (0-1) at 90±7 days.(Comments:The minimum and maximum values are from 0 to 6,and higher scores mean a worse outcome.)
Time frame: 90±7 days
National Institutes of Health Stroke Scale (NIHSS)
NIHSS score at 24±2 hours.(Comments:The minimum and maximum values are from 0 to 40, and higher scores mean a worse outcome.)
Time frame: 24±2 hours
National Institutes of Health Stroke Scale (NIHSS)
Proportion of subjects with ≥ 4 point reduction in NIHSS or reaching 0-1 at 7 ± 2 days or before discharge (whichever occurs first).(Comments:The minimum and maximum values are from 0 to 40, and higher scores mean a worse outcome.)
Time frame: 7±2days or discharge
Modified Rankin Scale(mRS)
Proportion of subjects with mRS scores of (0-2) at 90±7 days.(Comments:The minimum and maximum values are from 0 to 6,and higher scores mean a worse outcome.)
Time frame: 90±7 days
Modified Rankin Scale(mRS)
mRS scores at 90±7 days.(Comments:The minimum and maximum values are from 0 to 6,and higher scores mean a worse outcome.)
Time frame: 90±7 days
The new vascular events
Incidence of the new vascular events, ischemic stroke, hemorrhagic stroke, myocardial infarction and cardio-cerebral revascularization at 90±7 days. (including: carotid endarterectomy, intracranial and extracranial artery interventional therapy, intracranial and extracranial artery bypass surgery, coronary interventional or bypass therapy)
Time frame: 90±7 days
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Beijing Tiantan Hospital, Capital Medical University Beijing
Beijing, Beijing Municipality, China
Quanzhou First Hospital
Quanzhou, Fujian, China
Yue Bei People'S Hospital
Shaoguan, Guangdong, China
Hengshui people's Hospital (Harrison International Peace Hospital)
Hengshui, Hebei, China
Tangshan Gongren Hospital
Tangshan, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Baogang Hospital of Inner Monglia
Baotou, Inner Monglia, China
Inner Mongolia Baotou Hospital
Baotou, Inner Mongolia, China
Huai'an Second People's Hospital
Huai'an, Jiangsu, China
The Affiliated Hospital of Xuzhou Meidcal University
Xuzhou, Jiangsu, China
...and 18 more locations
Deaths
Vascular mortality at 90±7 days (mainly due to stroke, myocardial infarction or pulmonary embolism)
Time frame: 90±7 days
EQ-5D
EQ-5D scores at 90±7 days.(Comments:The minimum and maximum values are from 0 to 100,and higher scores mean a better outcome.)
Time frame: 90±7 days