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This study evaluates the addition of Ginkgo Diterpene Lactone Meglumine Injection to aspirin in the treatment of acute ischemic stroke.Half of patient will receive Ginkgo Diterpene Lactone Meglumine Injection(25mg once/day D1-D14) and aspirin(100mg once/day D1-D14) in combination, while the other half will receive aspirin(100mg once/day D1-D14).
This trial is a randomized, double-blind, placebo-controlled trial, A total of approximately 70 patients with acute ischemic stroke (5\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginkgo and aspirin | Active Comparator | Ginkgo Diterpene Lactone Meglumine Injection 25mg/5ml,once/day from Day 1 to Day 14. The injection was diluted with 250ml physiological saline,intravenous drip for about 3 hours;combined with Acetylsalicylic acid (Aspirin) given at a dose of 100 mg per day for 90 days. |
|
| aspirin | Placebo Comparator | Patients in the aspirin group received the same volume saline injection as placebo for 14 days plus aspirin at a dose of 100 mg per day for 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginkgo Diterpene Lactone Meglumine Injection | Drug | The injection was diluted with 250ml physiological saline,intravenous drip for about 3 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with NIHSS scores or NIHSS scores | Proportion of patients with National Institutes of Health Stroke Score (NIHSS) scores decrease ≥5 (Δ ≥ 5) or Modified Rankin Scale (mRS) scores decrease ≥2(Δ ≥ 2) from baseline to randomized 90 days. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| PL-11 AA at 24 hours and day 14 | Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of acetylsalicylic acid. | 24 hours,14 days |
| PL-11 ADP at 24 hours and day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunxiang Chen, Master of Medicine | Contact | +8618616537797 | 768449109@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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|
| Acetylsalicylic acid | Drug | Acetylsalicylic acid (Aspirin) given at a dose of 100 mg/d for 90 days. |
|
|
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of adenosine diphosphate.
| 24 hours,14 days |
| New vascular events defined as any event of the following: Any stroke (ischemic or hemorrhage) | All the new vascular events will be assessed by at least two neurologists based on neuroimaging and clinical feature. When there was disagreement, a third senior neurologist was consulted to reach a consensus decision. | 14 days |
| PL-11 COL at 24 hours and day 14 | Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of collagen. | 24 hours,14 days |
| PL-11 EPI at 24 hours and day 14 | Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of epinephrine. | 24 hours,14 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |