Acute Large Vessel Occlusion Stroke
Conditions
Interventions
TNK group:Patients with large vessel occlusion stroke and eTICI score of 2b50/67 after mechanical thrombectomy receive intra-arterial injection of tenecteplase (TNK) via microcatheter, with dose strat
Placebo group:Patients with large vessel occlusion stroke and eTICI score of 2b50/67 after mechanical thrombectomy receive intra-arterial injection of equal-volume placebo via microcatheter, in combin
Sponsors
Shenzhen Hospital of Southern Medical Unversity
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Clinically diagnosed with acute ischemic stroke; 3. Time from symptom onset to randomization =6; 8. Pre-stroke modified Rankin Scale (mRS) score 0–1, or mRS >1 but unrelated to neurological disease (e.g., amputation, blindness); 9. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of contraindications to intravenous thrombolysis (excluding time window); 2. Planned use of dual antiplatelet therapy within the first 24 hours post-thrombectomy; 3. Vascular imaging findings indicating carotid dissection, severe stenosis, or complete occlusion of the cervical segment requiring concurrent carotid stenting during thrombectomy; 4. Suspected cerebral vasculitis based on clinical history and vascular imaging; 5. Pregnant or lactating women; 6. Participation in another interventional clinical trial; 7. Intracranial hemorrhage confirmed by preoperative cranial CT or MRI; 8. Known inherited or acquired bleeding diathesis or coagulation factor deficiency; 9. Coagulopathy with INR >1.7 or use of novel anticoagulants within 48 hours of symptom onset; 10. Platelet count 220 µmol/L (2.5 mg/dL); 13. Severe contrast allergy (excluding mild rash) or absolute contraindication to iodinated contrast; 14. Suspected aortic dissection; 15. Major solid organ surgery or biopsy performed within the past month; 16. Any active bleeding or recent hemorrhage (e.g., gastrointestinal, urinary tract) within the past month; 17. Refractory hypertension uncontrolled by medication (persistent SBP >185 mmHg or DBP >110 mmHg); 18. Expected survival less than six months (e.g., malignancy, severe cardiopulmonary disease); 19. Any other condition deemed by the investigator unsuitable for study participation or posing significant risk to the patient (e.g., psychiatric disorder, cognitive or emotional impairment preventing understanding and/or adherence to study procedures and/or follow-up).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a modified Rankin Scale (mRS) score of 0–1 at 90 +/- 7 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in eTICI score before and after randomization;Change in infarct volume from baseline at 7 ± 1 days after randomization / at discharge, or at 48 ± 12 hours on MRI/NCCT;Tmax > 6 s volume at 24 (±12) hours after randomization;90+/-7-day mRS shift analysis, proportion of 0–2, proportion of 0–3;Proportion of patients with NIHSS 0–1 or =10-point reduction from baseline at 48+/-12 hours post-randomization;90+/-7-day EQ-5D-5L score;Safety endpoints: Symptomatic intracranial hemorrhage within 36 hours (per Heidelberg criteria); all-cause mortality at 90+/-7 days post-randomization; any intracranial hemorrhage within 36 hours post-randomization (per Heidelberg criteria).; | — |
Countries
China
Contacts
Public ContactHe XiongJun
Shenzhen Hospital of Southern Medical Unversity
Outcome results
None listed