teneteplase reperfusion therapy in acute ischemic cerebrovascular events-ⅳ(trace ⅳ)

Conditions: Tenecteplase; Minor Ischemic Stroke

Summary: the trial is a multicenter, prospective, open-label, blinded-endpoint randomized controlled design. participants with acute minor ischemic stroke (baseline nihss≤5) accompanied with dwi/flair mismatch will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.

the study will be a multicenter, prospective, open-label, blinded-endpoint randomized controlled trial (2 arms with 1:1 randomization). participants with acute minor ischemic stroke (baseline nihss≤5) within 12 hours of symptoms onset (symptom onset is defined by the "last seen normal" principle for wake-up stroke) accompanied with measurable neurological deficit and dwi/flair mismatch will be enrolled. the measurable neurological deficit is defined as impairment of language or motor function. participants will be randomized into 2 groups: intervention group (rhtnk-tpa): 0.25mg/kg, the maximum dose does not exceed 25mg. control group: standard medical care according to the guideline. the primary endpoint is excellent functional outcome (modified rankin scale score, mrs 0-1) at 90-day.

Eligibility criteria:
inclusion criteria 1. age ≥ 18 years; 2. can be treated with study drug within 12 hours of symptoms onset\*(\*symptom onset is defined by the "last seen normal" principle); 3. clinical diagnosis of minor ischemic stroke (baseline nihss≤5) with a measurable neurological deficit defined as impairment of language or motor function; 4. dwi/flair mismatch on magnetic resonance imaging. 5. pre-stroke mrs 0-1; 6. informed consent signed. exclusion criteria 1. contradictory or unable to complete mri examination. 2. planned or likely acute endovascular treatments (any angioplasty or vascular surgery); 3. nihss 1a \> 2; 4. known allergic to rhtnk-tpa; 5. known history of intracranial hemorrhage; 6. clinical stroke or serious head/spinal trauma within 3 months; 7. intracranial or spinal surgery within 3 months; 8. known history of gastrointestinal or urinary tract hemorrhage in the previous 21 days. 9. participants with a history of major surgery in the previous 14 days; 10. arterial puncture at a non-compressible site in the previous 7 days. 11. participants with intracranial tumors (excluding neuroectoderm origin, such as meningioma), huge intracranial aneurysm, or arterio-venous malformation. 12. intracranial hemorrhage (including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma) 13. participants with active visceral bleeding; 14. participants with aortic arch dissection; 15. participants with a known bleeding diathesis or with a platelet count \< 100×109/l; 16. participants with a systolic blood pressure \> 180 or a diastolic blood pressure \> 100 mmhg after repeated measurements and aggressive treatments; 17. blood glucose \ 22.2 mmol / l); 18. clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis); 19. receive intravenous thrombolysis within 24 hours; 20. receive direct oral anticoagulant therapy with international normalized ratio (inr) \> 1.7s or pt \> 15 s; 21. receive low molecular weight heparin or heparinoid within 24 hours; 22. receive thrombin inhibitors or factor xa inhibitors within 48 hours; 23. receive gp2b3a inhibitors within 72 hours; 24. participants who have large areas (greater than one third of middle cerebral artery territory) of obvious low density on the baseline ct scan; 25. participants with a seizure at onset thought to be presenting with postictal paralysis (todd's paralysis) mimicking stroke. 26. participants with severe infection, such as bacterial endocarditis, pericarditis, acute pancreatitis; 27. pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control; 28. participation in another clinical study with an experimental product in the previous 3 months; 29. participants deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.