Large-Artery Atherosclerotic Acute Ischemic Stroke
Conditions
Interventions
Control group:Standardized treatment based on guidelines + Placebo
intervention group:Standardized treatment based on guidelines + Hydroxysafflor Yellow A
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 85 years; 2. Meet the diagnosis of acute ischemic stroke (diagnosed according to the statement in the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023); 3. First-ever stroke or recurrent stroke without obvious neurological deficit (modified Rankin Scale [mRS] score =1 before the onset); 4. Onset of symptoms within 72 hours prior to enrollment; 5. Preliminary diagnosis of large artery atherosclerosis (LAA) subtype of ischemic stroke; 6. NIH Stroke Scale (NIHSS) score between 4 and 24 at enrollment with a combined motor score (items 5 and 6 of the NIHSS) =2; 7. Written informed consent obtained from the patient or a legally authorized representative.
Exclusion criteria
Exclusion criteria: 1. Neuroimaging findings (CT/MRI) indicating intracranial hemorrhagic diseases (e.g. hemorrhagic stroke epidural hematoma intracranial hematoma intraventricular hemorrhage subarachnoid hemorrhage etc.) brain tumors or brain trauma. 2. Severe disturbance of consciousness (NIHSS item Ia score =2). 3. Clinically suspected cardiogenic cerebral embolism (evidence of atrial fibrillation on electrocardiogram before enrollment and/or history of cardiac valvular disease or atrial fibrillation). 4.Patients who have received or intend to receive intravenous thrombolysis or endovascular interventional therapy (including mechanical thrombolysis arterial thrombolysis and angioplasty) for reperfusion or are expected to undergo endovascular therapy or surgery within the next 3 months. 5.Patients with severe osteoarthritis rheumatoid arthritis gouty arthritis etc. which lead to limb mobility dysfunction and affect neurological function examinatio. 6. Patients with poorly controlled hypertension: supine systolic blood pressure =220 mmHg or diastolic blood pressure =120 mmHg at randomization. 7. Patients with severe liver and renal insufficiency: ALT or AST >2.0 × upper limit of normal (ULN) and/or other known liver diseases (acute/chronic hepatitis liver cirrhosis etc.); serum creatinine >2.0 × ULN and/or known severe renal insufficiency. 8. Suffering from other life-threatening serious diseases (e.g. malignant tumors severe hematological digestive or other systemic diseases etc.) with an expected survival time of less than 3 months. 9. Women who are pregnant planning pregnancy or breastfeeding (childbearing potential with a negative pregnancy test). 10.History of major organ hemorrhage within 1 month (e.g. intracerebral hemorrhage gastrointestinal bleeding etc.). 11. Allergy to safflower or safflower extract products or history of severe allergies. 12. History or suspected history of alcohol or drug abuse. 13. Participation in another clinical trial within 3 months before randomization or are currently enrolled in another trial. 14. Any other condition that in the investigator's opinion makes the patient unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Favorable functional outcome (mRS=1); | — |
Secondary
| Measure | Time frame |
|---|---|
| Life quality evaluation (EQ-5D-5L);Barthel Index (BI) = 75;Distribution of mRS grades;Incidence of recurrent ischemic stroke;Barthel Index (BI) = 95;NIHSS score =1 or a reduction of =4 points from baseline;mRS 0-2; | — |
Countries
China
Contacts
Public ContactLinjuan Sun
No.1 Xiyuan Playground Haidian District Beijing
Outcome results
None listed