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| Name | Class |
|---|---|
| Xi'an Central Hospital | OTHER |
| Shaanxi Provincial People's Hospital | OTHER |
| The Third Hospital of PLA | UNKNOWN |
| Hanzhong Central Hospital |
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To investigate the efficacy and safety of hirudin plus aspirin therapy compared with warfarin in the secondary prevention of cardioembolic stroke due to nonvalvular atrial fibrillation.
For the patients with cardioembolic stroke due to atrial fibrillation,guidelines recommended warfarin as the secondary prevention therapy. But warfarin has its disadvantages such as risk of bleeding and the requirement of frequent INR monitoring. The underuse of warfarin is a prominent problem in China. In our study, patients with cardioembolic stroke were treated with hirudin plus aspirin or warfarin. The aim of our study was to compare efficacy and safety of hirudin plus aspirin and warfarin in secondary prevention of cardioembolic stroke due to nonvalvular atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hirudin plus aspirin | 14 days after stroke onset, patients in the hirudin plus aspirin group received natural hirudin 0.75g, three times a day and aspirin 100mg, once daily. |
| |
| Warfarin | 14 days after stroke onset, patients in warfarin group were given an initial dose of 1.25mg of warfarin,once daily. 3 days later, INR of patients was checked every three days and the dose of warfarin was adjusted until reach the target range of 2 to 3. Since then INR monitoring was performed at 1, 2, 3, 6, 9, 12 months after stroke onset, targeting an INR between 2 and 3 and the dose of warfarin was adjusted accordingly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hirudin plus aspirin | Drug | natural hirudin 0.75g, three times a day (Brand name: Maixuekang capsule, Guizhou Xinbang Pharmaceutical Co., China) and aspirin 100mg, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy outcome event: the recurrence of cardioembolic stroke | To compare the recurrence of cardioembolic stroke in hirudin plus aspirin group and the warfarin group. | One year after stroke onset |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome events | Intracranial hemorrhage and other bleeding events, any death and other serious adverse events | One year after stroke onset |
Inclusion Criteria:
Exclusion Criteria:
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Cardioembolic stroke patients due to nonvalvular atrialf ibrillation.
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| Name | Affiliation | Role |
|---|---|---|
| wen jiang, MD,PhD | The Department of Neurology , Xijing Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D000083262 | Embolic Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D006629 | Hirudins |
| D001241 | Aspirin |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D058833 | Antithrombin Proteins |
| D015843 | Serpins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| OTHER |
| Xianyang 215 hospital | UNKNOWN |
| Yulin Second Hospital | UNKNOWN |
| Yan'an University Affiliated Hospital | OTHER |
| Baoji Central Hospital | OTHER |
| Ankang Central Hospital | OTHER |
| Baoji People's Hospital | UNKNOWN |
| Yan'an People's Hospital | OTHER |
| 451 Hospital | UNKNOWN |
| Shangluo Central Hospital | OTHER |
| Central Hospital of China Railway 20th Bureau | UNKNOWN |
| Xiangyang Central Hospital | OTHER |
| Xi'an Ninth Hospital | UNKNOWN |
| Shangluo Second People's Hospital | UNKNOWN |
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| Warfarin | Drug | an initial dose of 1.25mg once daily. Three days later, INR of patients was checked every three days and the dose of warfarin was adjusted until reach the target range of 2 to 3. Since then INR monitoring was performed at 1, 2, 3, 6, 9, 12 months after stroke onset, targeting an INR between 2 and 3 and the dose of warfarin was adjusted accordingly. |
|
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011506 |
| Proteins |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |