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The objective of this study is to investigate the efficacy and safety of BNG-1 in patients with ischemic stroke. The efficacy assessment will be based on the functional outcome while the safety will be reviewed by the adverse events and laboratory examinations.
The primary endpoint will be performed on the 12 weeks after study drug administered and will compare the favorable rate between treatment with Aspirin alone and combination treatment with BNG-1 and Aspirin in patients with ischemic stroke. The favorable to therapy will be determined if all of the following occurs: alive, Modified Rankin Scale (MRS) < 3, Barthel Index (BI) >= 60.
Secondary objectives are to compare the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BNG-1 plus Aspirin | Active Comparator | BNG-1 3 grams TID plus Aspirin 100mg QD for 4 weeks |
|
| Aspirin | Sham Comparator | Aspirin 100mg QD for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNG-1 | Drug | BNG-1 3 grams TID for 4 weeks |
| |
| Aspirin |
| Measure | Description | Time Frame |
|---|---|---|
| Favorable rate | Favorite rate: A composite of mortality (alive), modified Rankin Scale < 3, AND Barthel Index (BI)>=60 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Favorable rate | 12 weeks | |
| Barthel index | 12 weeks | |
| Modified Rankin Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsong-Hai Lee, MD, PhD | Chief of Stroke Center, Linkou Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stroke center, Department of Neurology, Linkou Chang Gung Memorial Hospital | Kweishan | Taoyuan | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26138124 | Derived | Hsieh CY, Lin HJ. Letter by Hsieh and Lin Regarding Article, "Acute Reperfusion Therapy and Stroke Care in Asia After Successful Endovascular Trials". Stroke. 2015 Aug;46(8):e198. doi: 10.1161/STROKEAHA.115.010253. Epub 2015 Jul 2. No abstract available. |
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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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| Drug |
Aspirin 100 mg QD for 4 weeks |
|
| 12 weeks |
| National Institute of Health Stroke Scale | 12 weeks |
| Extended Glasgow Outcome Scale | 12 weeks |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |