Acute ischemic stroke
Conditions
Interventions
Control Group:placebo matched with Tenecteplase (rhTNK-tPA) + Aspirin 300 mg
rhTNK-tPA Group:tenecteplase (rhTNK-tPA) matched + Aspirin placebo
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age = 18 years; 2.The onset time is 4.5–9 hours. For patients who wake up with symptoms or whose onset time is unknown, calculation begins from the time the symptoms are discovered. 3.MRI imaging requirements: there is a DWI/FLAIR mismatch (DWI shows enhancement while FLAIR does not show significant enhancement), the volume of the infarct does not exceed 1/3 of the middle cerebral artery territory, 1/2 of the anterior cerebral artery territory, or 1/2 of the posterior cerebral artery territory. 4.The NIHSS score at randomization was 4-25 points; 5.First onset or mRS =1 before onset; 6.Sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Unable to cooperate with or complete an MRI scan; 2.Patients scheduled to undergo endovascular treatment; 3.Pre-onset mRS score = 2; 4.The patient has a severe, life-threatening, or disabling disease, with an expected life expectancy of less than 3 months. 5.Other absolute or relative contraindications to standard intravenous thrombolysis include, but are not limited to: intracranial hemorrhage (including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma, etc.); history of prior intracranial hemorrhage; severe head trauma or stroke within the past 3 months; intracranial tumors, large intracranial aneurysms; recent (within 3 months) intracranial or spinal surgery; major surgery within the past 2 weeks; gastrointestinal or urinary tract bleeding within the past 3 weeks; active visceral bleeding; aortic arch dissection; arterial puncture at a non-compressible site in the past week; hypertension uncontrolled despite active antihypertensive treatment; uncontrolled hypertension is defined as a repeated blood pressure measurement at least 10 minutes apart, taken 3 times, with systolic pressure >185 mmHg or diastolic pressure >110 mmHg; acute bleeding tendencies, including platelet count 1.7 or PT>15s; use of thrombin inhibitors or Xa factor inhibitors within the past 48 hours, or various abnormal laboratory tests (such as APTT, INR, TT, or Xa factor activity tests); blood glucose 22.22 mmol/L; cranial CT or MRI indicating large-area infarction (area >1/3 of the territory supplied by the middle cerebral artery); pregnancy or breastfeeding. 6.Allergic to the active ingredient rhTNK-tPA or any other components; 7.The patient is expected to be unable to complete follow-up; 8.Already joined another study that conflicts with the current study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients fully independent in daily living (mRS 0-1) at 90 days (±7); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the distribution of mRS scores at 90±7 days and the proportion of patients with mRS 0-1;Proportion of patients with new vascular events within 90±7 days (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death);Proportion of subjects with an NIHSS score of 0-1 or an improvement of =2 points from baseline at 36 hours, 7±1 days, or before discharge (whichever occurs first);Quality of Life Assessment;Assessment of daily functioning;Proportion of patients with an mRS score of 0-2 at 90±7 days; | — |
Countries
China
Contacts
Public ContactBo Song
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed