To integrate large-scale RCT data on clinical symptoms, TCM syndromes, prognosis, and multi-omics profiles, construct a spatiotemporal dynamic network for disease-syndrome evolution of acute ischemic stroke (AIS) in the acute and recovery phases, evaluate the efficacy and safety of sequential treatment with Erigeron breviscapus-Dengzhan Shengmai for AIS, and provide evidence for precise syndrome differentiation and individualized therapy.Secondary Objective:To investigate the optimal time window and key intervention targets of sequential treatment with Erigeron breviscapus-Dengzhan Shengmai for AIS.
Age ≥ 18 years
Meeting the diagnostic criteria for acute ischemic stroke in accordance with the Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China 2023
Within 48 hours after the first onset
National Institutes of Health Stroke Scale (NIHSS) score ranging from 4 to 25 points
Pre-stroke modified Rankin Scale (mRS) score ≥ 2
Patients with transient ischemic attack (TIA), complicated with cerebral hemorrhage or subarachnoid hemorrhage
patients with brain tumor, Alzheimer's disease, psychosis, or a confirmed diagnosis of dementia
Patients undergoing endovascular thrombectomy
Parallel
Dengzhan Shengmai - Erigeron breviscapus sequential intervention
DrugTrial group: Acute phase (0-7 days after onset): Breviscapine of Dengzhan Xixin injection 40 mL diluted with 250 mL normal saline, intravenous drip, once daily. Recovery phase (8-90 days): Dengzhan Shengmai capsules 0.18 g/capsule × 2 capsules, orally, three times daily.
corresponding control group sequential intervention
DrugControl group: Acute phase (0-7 days after onset): Normal saline 250 mL, intravenous drip, once daily. Recovery phase (8-90 days): Placebo capsules (starch) 0.18 g/capsule × 2 capsules, orally, three times daily.
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 3 months in the treatment group versus the control group.
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 3 months in the treatment group versus the control group.
The difference in the change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score at 3 months between the two groups.
The difference in the change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score at 3 months between the two groups.
Distribution of modified Rankin Scale (mRS) scores in both groups at 3 months.
Distribution of modified Rankin Scale (mRS) scores in both groups at 3 months.
Incidence of symptomatic intracerebral hemorrhage events within 7 days in both groups.
Incidence of symptomatic intracerebral hemorrhage events within 7 days in both groups.
Incidence of early neurological deterioration events within 7 days in both groups (defined as: an increase of ≥2 points in the NIHSS scores reflecting motor function and consciousness, or an increase of ≥4 points in the total NIHSS score within 7 days).
Incidence of early neurological deterioration events within 7 days in both groups (defined as: an increase of ≥2 points in the NIHSS scores reflecting motor function and consciousness, or an increase of ≥4 points in the total NIHSS score within 7 days).
The differences in scores on the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) between the two groups at 6 months.
The differences in scores on the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) between the two groups at 6 months.
The difference in the Activities of Daily Living (ADL) scale scores between the two groups at 6 months.
The difference in the Activities of Daily Living (ADL) scale scores between the two groups at 6 months.
All-cause mortality and recurrence rate of cardiovascular events in both groups were followed up until death or 6 months after treatment.
All-cause mortality and recurrence rate of cardiovascular and cerebrovascular events in both groups followed until death or 6 months after treatment.
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Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead sponsor
Nanfang Hospital, Southern Medical University
Collaborator
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