Large-Artery Atherosclerotic Acute Ischemic Stroke
Conditions
Interventions
Control group:basic treatment with Qilong Capsule Simulation Agent
intervention group:basic treatment with Qilong Capsule.
Sponsors
No.1 Xiyuan Playground Haidian District Beijing
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–85 years old; 2. Diagnosed with acute ischemic stroke according to the *Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023* and the National Institutes of Health Stroke Scale (NIHSS) score is 4–25 before thrombolysis; 3. Thrombolytic treatment has been initiated within 4.5 hours after onset; 4. Modified Rankin Scale (mRS) score =1 before onset; 5. The medication can be used within 24 hours after intravenous thrombolysis; The patient or his/her legal guardian has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Neuroimaging studies (CT/MRI) indicate intracranial hemorrhagic diseases (e.g. hemorrhagic stroke epidural hematoma intracerebral hematoma intraventricular hemorrhage subarachnoid hemorrhage etc.) brain tumor or traumatic brain injury. 2. Patients with severe impairment of consciousness (NIHSS score =2 in Item ?a). 3. Patients with dysphagia (Water Swallowing Test by Wada =Grade 3). 4. Patients with other diseases that cause motor impairment of the limbs (severe osteoarthritis rheumatoid arthritis gouty arthritis etc.) resulting in motor dysfunction that affects neurological examination. 5. Acute bleeding tendency including but not limited to: 1) Known history of bleeding or genetic predisposition to severe bleeding disorders currently or within the past 6 months. 2) Administration of heparin within the past 48 hours with activated partial thromboplastin time (aPTT) exceeding the upper limit of normal measured by the laboratory. 3) Platelet count below 100000/mm³ at screening. 4) Any history of central nervous system injury (e.g. tumor aneurysm intracranial or spinal surgery). 5) Traumatic external cardiac massage childbirth or non-compressible vascular puncture (e.g. subclavian vein or jugular vein puncture) within the past 10 days. 6) Known history of suspected intracranial hemorrhage or suspected subarachnoid hemorrhage caused by aneurysm. 7) Tumors with increased risk of bleeding. 8) Documented history of ulcerative gastrointestinal disease esophageal varices aneurysm or arteriovenous malformation within the past 3 months. 6. Major trauma or major surgery within the past 3 months (as assessed by the investigator). 7. Poorly controlled hypertension such as systolic blood pressure (BP) >185 mmHg or diastolic BP >110 mmHg. 8. History of drug or food allergies known allergies to Qilong Capsule or allergies to earthworms and their extracts (e.g. lumbrokinase) or excipients. 9. Pregnant planning to become pregnant or breastfeeding women (negative pregnancy test for women of childbearing age). 10. Severe hepatic or renal insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 times the upper limit of normal and/or other known liver diseases such as acute or chronic hepatitis cirrhosis etc.; serum creatinine >2.0×ULN and/or known severe renal insufficiency. 11. Patients with other life-threatening severe diseases (malignant tumors severe hematologic gastrointestinal or other systemic diseases) with an expected survival time of less than 3 months. 12. Patients who must or are expected to continue taking restricted medications or any drugs that may interfere with the safety of the trial. Other situations deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Favorable functional outcome (mRS=1); | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite cerebrovascular events (ischemic stroke intracerebral hemorrhage myocardial infarction and vascular death);Barthel Index (BI) = 95;mRS 0-2;NIHSS score;NIHSS score =0 or a reduction of =4 points from baseline;Distribution of mRS grades;Life quality evaluation (EQ-5D-5L); | — |
Countries
China
Contacts
Public ContactLinjuan Sun
No.1 Xiyuan Playground Haidian District Beijing
Outcome results
None listed