The trial is prospective, 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 to 0.25mg/kg 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 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients. Imagine is performed with CT or MRI acutely with imaging follow-up at 24-36 hours. The sample size is 1630.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,630
Alteplase 0.9mg/kg are being used.
Tenecteplase 0.25mg/kg are being used.
Modified Rankin Scale(mRS)
Proportion of subjects with mRS scores of (0-1) at 90±7 days.
Time frame: 90±7 days
National Institutes of Health Stroke Scale (NIHSS)
NIHSS score at 24±2 hours.
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)
Time frame: 7±2days or discharge
Modified Rankin Scale(mRS)
Proportion of subjects with mRS scores of (0-2) at 90±7 days.
Time frame: 90±7 days
Modified Rankin Scale(mRS)
mRS scores at 90±7 days.
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
EQ-5D
EQ-5D scores at 90±7 days.
Time frame: 90±7 days
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