Acute ischemic stroke
Conditions
Interventions
Tenecteplase dose group A (dose A: 0.03125mg/kg) :Intra-arterial Tenecteplase thrombolysis (dose A: 0.03125mg/kg) in occluded arteries after successful endovascular treatment.
Tenecteplase dose group B (dose B: 0.0625mg/kg) :Intra-arterial Tenecteplase thrombolysis (dose B: 0.0625mg/kg) in occluded arteries after successful endovascular treatment.
Control group:Endovascular treatment
Sponsors
The First Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Aged = 18 years; 2.The time from onset to randomization was within 24 hours; 3.Large vessel occlusive stroke in the anterior circulation confirmed by CTA/MRA (Including intracranial segment of internal carotid artery and M1 or M2 segment of middle cerebral artery) and the vessel responsible for the signs and symptoms of acute ischemic stroke; 4. Alberta Stroke Program Early Diagnosis (ASPECTS) score = 6 based on NCCT; 5. NIHSS score = 6; 6. Successful endovascular thrombectomy (eTICI 2b50-3); 7. Total pass numbers = 3; 8. Written informed consent signed by patients or their family members.
Exclusion criteria
Exclusion criteria: 1. NIHSS score on admission =25; 2. Intracranial hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI); 3. Treated by intravenous thrombolysis; 4. Prestroke mRS score =2 ; 5. Intraoperative DSA angiography suggests vessel penetration, entrapment, and extravasation of contrast medium; 6. Pregnant or lactating patients; 7. Allergic to contrast agents or Tenecteplase; 8.Systolic blood pressure>185mmHg or diastolic blood pressure>110mmHg, and cannot be well controlled by oral antihypertensive drugs.; 9. Genetic or acquired bleeding disposition with anticoagulation factor deficiency or already taking oral anticoagulants within 48 hours and INR > 1.7; 10. Blood glucose 22.2 mmol/L (400 mg/dl), platelets 220 µmol/L (2.5mg/dl)); 13. Any terminal illness with a life expectancy of less than 6 months; 14. Intracranial aneurysm, arteriovenous malformation; 15. Brain tumors with occupying effect on imaging; 16. Puncture to recanalization time > 90 min; 17. Current participation in another clinical trial; 18. Unlikely to be available for 90-day follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a mRS 0 to 1 at 90 (±14) days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with a mRS 0 to 2 at 90 (±14) days;Shift in the distribution of mRS score at 90 (±14) days;Proportion of patients with angiographic changes on the eTICI score after Intra-arterial Tenecteplas;Changes in the NIHSS score 5-7 days after surgery or at discharge;Quality of life measured with the EQ-5D-3L at 90 (±14) days;Symptomatic intracerebral hemorrhage (sICH) rate within 24 h;Mortality at 90 (±14) days; | — |
Countries
China
Contacts
Public ContactZhou Zhenhua ; Aquilla S. Turk
The First Affiliated Hospital of the Army Medical University;The Prisma Healthcare Upstate Network in Greenville, South Carolina, USA
Outcome results
None listed