Study of Tenecteplase With Butylphthalide to Improve Recovery in Adults Aged 18-80 With Mild Disabling Acute Ischemic Stroke Treated Within 4.5 Hours

What this Trial Is About

Researchers are studying the use of Tenecteplase TNK combined with Butylphthalide NBP in patients who have experienced mild disabling acute ischemic stroke AIS. This large, randomized, double-blind trial compares the effects of TNK plus NBP versus TNK alone to see if the combination improves neurological function and recovery. Patients eligible for the study are adults aged 18 to 80 years who have had a stroke within 4.5 hours and meet specific neurological severity criteria. Participants are randomly assigned to one of two groups. The combination group receives a single intravenous dose of TNK followed by intravenous NBP twice daily for 7 days, then oral NBP capsules three times daily until Day 14. The control group receives the same TNK dose followed by a matching placebo infusion and capsules on the same schedule. Treatments are administered during hospitalization and continue after discharge if needed. Throughout the 90-day study period, participants undergo assessments including stroke severity scores, functional recovery measured by the Modified Rankin Scale, quality of life surveys, and imaging to evaluate brain tissue salvage. Safety monitoring tracks adverse events like bleeding or vascular complications. The main outcome is the proportion of patients achieving minimal disability by 90 days, with additional evaluations of neurological improvement and stroke recurrence.

Effects of Butylphthalide Enhanced With Tenecteplase on Neurological Function in Mild Disabling Acute Ischemic Stroke