Ischemic Stroke
Conditions
Interventions
Western medicine control group:Acute phase (Day 1-21): Aspirin (100 mg/day) + Clopidogrel (75 mg/day) + Dragonfly Leech Capsule placebo
Recovery phase (Day 22-90): Aspirin alone (100 mg/day).
TCM Treatment Group:Acute phase (Day 1-21): Aspirin (100 mg/d) + Longshengzhi Capsules (5 tablets per dose, three times daily) + Clopidogrel analog
Recovery phase (Day 22-90): Aspirin alone (100 mg/d).
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily signed the informed consent form; 2. Age between 40 and 80 years old; 3. Meets thediagnosis criteria for acute ischemic stroke and belongs to non-disabling mild stroke or high-risk TIA within 72 hours of onset; 4. Meets thediagnosis criteria for ischemic stroke with qi deficiency and blood stasis syndrome; 5. Randomized drug administration is expected to be conducted within 72 hours of the acute phase of this episode; 6. During the screening period, before any drug treatment, the National Institutes of Health Stroke Scale (NIHSS) score is =3 points based on this episode. If the patient has TIA, the ABCD2 score is =4 points; 7. During the screening period, the S2TOP-BLEED bleeding risk assessment score is =11 points (regardless of group, baseline antiplatelet therapy is considered as 5 points).
Exclusion criteria
Exclusion criteria: 1. Severe heart disease, heart failure, liver and kidney dysfunction (ALT elevated, more than 3 times the upper limit of normal; serum creatinine elevated, more than 2 times the upper limit of normal), respiratory failure, malignant tumors, gastrointestinal bleeding, etc., which are expected to be unable to complete follow-up; 2. Patients with mental illness; pregnant or breastfeeding women; 3. Silent cerebral infarction without symptoms or localized signs; 4. Patients who have undergone intracranial or extracranial arterial stenosis angioplasty; 5. mRS score >1 before this stroke; patients with mRS grade 5 in this stroke; 6. Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc.; with coagulation disorders, systemic bleeding history, or history of thrombocytopenia or neutropenia; 7. Ischemic stroke caused by reasons other than atherosclerosis, such as: cardioembolic stroke, arteritis, polycythemia vera, thrombocytosis, sickle cell anemia, thrombotic thrombocytopenic purpura, disseminated intravascular coagulation, cerebral amyloid angiopathy, Moyamoya disease, intracranial vascular malformations, etc.; 8. Patients who cannot take medication on time for other reasons; patients currently participating in other clinical trials; 9. Other reasons deemed unsuitable for clinical trials by the study personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day net clinical outcomes incidence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence rate of major/clinically relevant bleeding within 90 days.;90-Day Modified Rankin Scale (mRS) Score;NIHSS score during the acute phase;Traditional Chinese Medicine (TCM) Syndrome Efficacy Scoring;Barthel Index (BI) Assessment; | — |
Countries
China
Contacts
Public ContactZheng Guoqing
The First Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed