ischemic stroke
Conditions
Interventions
Experimental Group:TNK(0.25mg/Kg, with a maximum of 25mg) plus standard medical treatment
Sponsors
Tianjin Huanhu Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years; 2.Onset time between 4.5-24 hours (for wake-up stroke or unwitnessed stroke, onset time refers to the time the patient was last known to be well; 3.NIHSS score >=4,NIHSS Scale item 5(motor arm) or irem 6(motor leg) >=2; 4.Complete the head MRI and intracranial vascular examination (MRA or CTA), and the images should meet the following conditions: 4.(1).A mismatch between DWI and FLAIR on MRI; 4.(2).Diffusion weighted imaging (DWI) reveals a single, isolated deep subcortical infarction; 4.(3).The responsible vessel is either the cisternar artery (LSA) or pontine perforating artery (PPA), with DWI lesions exhibiting one of these characteristics(A or B): 4.(3). (A). LSA supply area: Comma-shaped infarction extending vertically from base to apex in coronal view, or axial DWI involvement across >=3 consecutive layers (5-7 mm thickness). 4.(3).(B). PPA supply area: Axial DWI showing infarction spanning deep pontine to ventral pontine regions. 4. (4).The responsible vessel demonstrates >=50% luminal narrowing. 5.Signed informed consent by the patient or legally authorized representative.
Exclusion criteria
Exclusion criteria: 1.Pre-stroke mRS score >= 2; 2.ICH, subarachnoid haemorrhage or other brain haemorrhage,intracranial arteriovenous malformation or aneurysm,brain abscess,malignant intracranial neoplasm,or other non-acute ischaemic stroke identified at baseline; 3.Cardiogenic Cerebral Embolism; 4.Stroke caused by other identifiable causes; 5.Contraindications for IVT:5. (1) Intracranial hemorrhage (including hemorrhage in the brain parenchyma, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma, etc.); 5. (2) History of intracranial hemorrhage; 5. (3) Severe head trauma or stroke within the last 3 months; 5. (4) Intracranial tumors, giant intracranial aneurysms; 5. (5) Intracranial or spinal surgery within the last 3 months; 5. (6) Major surgery within the last 2 weeks; 5. (7) Gastrointestinal or urinary system hemorrhage within the last 3 weeks; 5. (8) Active visceral hemorrhage; 5. (9) Aortic dissection; 5. (10) Arterial puncture at a site not easily compressed for hemostasis within the last week; 5. (11) Elevated blood pressure: systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 100 mmHg; 5. (12) Acute bleeding tendency, including platelet count 1.7 or PT > 15 seconds; 5. (15) Use of thrombin inhibitors or factor Xa inhibitors within 48 hours, or various laboratory test abnormalities (such as APTT, INR, platelet count, ECT, TT or factor Xa activity measurement, etc.); 5. (16) Blood glucose 22.22 mmol/L; 5. (17) Large area infarction (infarction area > 1/3 of the middle cerebral artery territory) indicated by head CT or MRI. 6.Pregnancy; 7.Allergy to study drugs; 8.Combine with other serious organ diseases; 9.Participation in other clinical trials within 3 months or ongoing trial enrollment; 10.Patient deemed unsuitable for the trial by site investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Excellent recovery assessed by the ratio of modified Rankin Scale (mRS) score of 0-1 (%) at 90 days;The incidence of symptomatic intracerebral hemorrhage (sICH) at 36 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ordinal distribution of mRS at 90 days;Proportion of patients with mRS score 0-2 at 90 days;Rate of early neurological improvement at 72 hours from baseline;Incidence of stroke deterioration at 7 days;Incidence of stroke recurrence and other vascular events at 90 days;Mortality rate at 90 days;Main systemic bleeding; | — |
Countries
China
Contacts
Public ContactJialing Wu
Tianjin Huanhu Hospital
Outcome results
None listed