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| ID | Type | Description | Link |
|---|---|---|---|
| 2022YFC3501104 | Other Grant/Funding Number | Ministry of Science and Technology of the People´s Republic of China |
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The primary purpose of this study is to investigate the effectiveness of Ginkgo Diterpene Lactone Meglumine (GDLM) for patients with acute ischemic stroke (AIS) in real-world settings.
The randomized controlled trial (RCT) of GDLM for the treatment of AIS was published in JAMA Network Open, titled "Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial." This study provided valuable insights into the efficacy and safety of GDLM in improving functional recovery for patients with AIS. However, the generalizability of these findings to real-world medical settings remains unclear, as the trial was conducted under controlled conditions that may not fully reflect routine clinical practice. To address this gap, we will conduct this study to further explore the effectiveness of GDLM in a real medical environment. Using routine clinical care data for real-world evidence, we aim to investigate the treatment's impact on a broader and more diverse patient population. This approach will allow us to better understand the practical application of GDLM in everyday clinical settings, including its potential benefits and challenges when used outside the confines of a RCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GDLM group | AIS patients received GDLM and guideline-standardized treatment within 48 hours of symptom onset |
| |
| Non-exposed Group | AIS patients initiated guideline-standardized treatment within 48 hours of symptom onset without exposure to Ginkgo-derived preparations. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginkgo Diterpene Lactone Meglumine | Drug | The specific administration protocol (including time of initiation, dosage, and treatment duration) should be strictly adhered to as per the physician's prescription and meticulously documented in the case report forms (CRFs). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with an mRS score of 0 or 1 | Modified Rankin Scale (mRS) is a 6-point ordinal scale from 0 [no symptoms] to 5 [severe disability] when excluding mortality, with lower scores indicating better functional outcome) | on day 90 after onset |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with an mRS score of 2 or less | Modified Rankin Scale (mRS) is a 6-point ordinal scale from 0 [no symptoms] to 5 [severe disability] when excluding mortality, with lower scores indicating better functional outcome) | on day 90 after onset |
| Distribution of mRS scores |
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Inclusion Criteria:
Exclusion Criteria:
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AIS patients within 48 hours of symptom onset from certified stroke centers across China
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sijin Wang, PHD | Contact | +86-17812051019 | 20230941128@bucm.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ying Gao, PHD | Dongzhimen Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gansu Provincial People's Hospital | Lanzhou | Gansu | 730000 | 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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|
Modified Rankin Scale (mRS) is a 6-point ordinal scale from 0 [no symptoms] to 5 [severe disability] when excluding mortality, with lower scores indicating better functional outcome) |
| on day 90 after onset |
| Incidence of new-onset stroke events (ischemic stroke or hemorrhagic stroke) | within 90 days after onset |
| Mortality rate | within 90 days after onset |
| Incidence of severe or moderate bleeding events (as defined by GUSTO criteria) | during hospital stay (up to 14 days) |
| Harbin Second Hospital | Harbin | Heilongjiang | 150000 | China |
|
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150000 | China |
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| Henan Provincial People's Hospital | Zhengzhou | Henan | 450000 | China |
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| Jiangsu Geriatric Hospital | Nanjing | Jiangsu | 210000 | China |
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| Jiangsu Provincial Hospital of Traditional Chinese Medicine | Nanjing | Jiangsu | 210000 | China |
|
| Xuzhou Hospital of Traditional Chinese Medicine | Xuzhou | Jiangsu | 221000 | China |
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| The First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| Affiliated Hospital of Jining Medical University | Jining | Shandong | 272000 | China |
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| Xian Changan District Hospital | Xian | Shanxi | 710000 | China |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |