Stroke
Conditions
Interventions
Combination therapy group:Intravenous t-PA thrombolysis plus An-Gong Niu-Huang pills
Control group:Intravenous t-PA thrombolysis plus standard stroke-unit care
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1: Aged 18–80 years, of any sex. 2: Time from symptom onset to initiation of thrombolysis = 4.5 hours, with acute ischemic stroke confirmed by imaging (CT or MRI). 3: Baseline NIHSS score 4–25. 4: Deemed eligible for t-PA thrombolysis upon evaluation according to the Guidelines for Intravenous Thrombolytic Therapy in Acute Ischemic Stroke. 5: Able to commence oral administration of An-Gong Niu-Huang pills within 2 hours after completion of thrombolysis. 6: Written informed consent must be provided by the participant or a legally authorized representative.
Exclusion criteria
Exclusion criteria: 1: Imaging evidence of intracranial hemorrhage or any absolute contraindication to intravenous t-PA thrombolysis; 2: Baseline NIHSS score 25, or ASPECTS < 6 indicating a large-area infarct. 3: Severe hepatic impairment or renal insufficiency. 4: Pregnant or breastfeeding women, or those planning to conceive within the 90-day follow-up period. 5: Use within the past 14 days of anticoagulant or antiplatelet drugs affecting coagulation (e.g., warfarin, dabigatran, rivaroxaban) or any traditional Chinese medicine preparation containing An-Gong Niu-Huang pill components. 6: Known hypersensitivity or history of severe adverse reactions to any component of An-Gong Niu-Huang pills-including but not limited to bovine calculus (or its artificial substitute), musk (or synthetic muscone), pearl, realgar (or its artificial equivalent), or any other excipients. 7: Presence of other severe comorbidities that could affect prognosis or study assessments (e.g., active malignancy, end-stage cardiopulmonary disease). 8: Patients whom the investigators deem unable to adhere to follow-up or likely to have poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving a modified Rankin Scale (mRS) score of 0–2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in NIHSS score;All-cause mortality;Incidence of symptomatic intracranial hemorrhage (sICH);Drug-related adverse events (AEs/SAEs); | — |
Countries
China
Contacts
Public ContactLi chaoqian
Guangxi Medical University
Outcome results
None listed