ischemic cerebrovascular disease
Conditions
Interventions
Experimental group:Recombinant human TNK tissue plasminogen activator for injection
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. 4.5h = 1.8, mismatch volume >= 15mL); 7. Subjects or guardians voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are planning to undergo interventional therapy; 2. Patients known to be allergic to rhTNK-tPA; 3. Those with rapid improvement of symptoms at the discretion of the investigator; 4. NIHSS consciousness score 1a > 2, or patients with epileptic seizures during stroke, hemiplegia after epileptic seizures or combined with other neurological/psychiatric diseases and unable to cooperate or unwilling to cooperate; 5. Severe, persistently elevated blood pressure (systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 100 mmHg) that is ineffective for drug control; 6. Blood sugar 22.2mmol/L (random blood sugar measuring device can be used); 7. Active internal bleeding with high bleeding risk, such as: major surgery, trauma, or bleeding in the gastrointestinal or urinary tract within the first 21 days, or arterial puncture at the non-compressible site within the first 7 days; 8. Any known coagulation deficiency, such as INR > 1.7 or prothrombin time > 15 seconds for currently used vitamin K antagonists, or use of a direct thrombin inhibitor or a newer oral anticoagulant NOAC within the past 48 hours (unless the effect can be reversed with idacilizumab) or sensitivity laboratory test values above the upper limit of normal (eg activated partial thromboplastin time (aPTT), international normalized ratio (INR), platelet count, thrombin time (TT), or appropriate factor Xa activity assay), or an increase in aPTT above the upper limit of normal in the past 24 hours with heparin; 9. Known platelet function defect or platelet count less than 100 x 10^9/L (but can include patients taking antiplatelet drugs); 10. Ischemic stroke or myocardial infarction in the previous 3 months, intracranial hemorrhage, severe traumatic brain injury or intracranial or spinal surgery in the previous month, or known intracranial tumors (except neuroectodermal tumors, such as meningiomas), arteriovenous malformations, or giant intracranial aneurysm criteria; 11. The life expectancy of the patient does not exceed 1 year; 12. Those who cannot complete the CTP or PWI examination; 13. Head CT or MRI suggests large infarction (infarct size > 1/3 of the middle cerebral artery blood supply area); 14. CT or MRI diagnosed as acute or old intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma); 15. Patients with multiple vascular occlusions (such as bilateral middle cerebral artery occlusion, middle cerebral artery combined with basilar artery occlusion, etc.); 16. Pregnant patients, breastfeeding or patients who are unable to meet the requirements of contraception; 17. Failure to comply with the trial protocol or follow-up requirements; 18. Any situation that the investigator believes may cause harm to the patient or affect the patient's participation in the study if the study treatment is initiated; 19. Participated in other interventional clinical trials within three months.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with NIHSS score 6s improved by 90% compared with before);NIHSS change from baseline at 7 days;Mortality at 90 days; | — |
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with mRS 0-1 at 90 days; | — |
Countries
China
Contacts
Public ContactWang Yongjun
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed