Atrial Fibrillation, Cardioembolic Stroke
Conditions
Keywords
atrial fibrillation, cardioembolic stroke, Hirudin, aspirin, warfarin
Brief summary
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.
Detailed description
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.
Interventions
DRUGhirudin plus aspirin
natural hirudin 0.75g, three times a day (Brand name: Maixuekang capsule, Guizhou Xinbang Pharmaceutical Co., China) and aspirin 100mg, once daily
DRUGWarfarin
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.
Sponsors
Xi'an Central Hospital
Shaanxi people's Hospital
The Third Hospital of PLA
Hanzhong Central Hospital
Xianyang 215 hospital
Yulin Second Hospital
Yan'an University Affiliated Hospital
Baoji Central Hospital
Ankang Central Hospital
Baoji People's Hospital
Yan'an people's Hospital
451 Hospital
Shangluo Central Hospital
Central Hospital of China Railway 20th Bureau
Xiangyang Central Hospital
Xi'an Ninth Hospital
Shangluo Second People's Hospital
Xijing Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age of 18 or older with NVAF-related cardioembolic stroke 2. diagnosis of cardioembolic stroke conformed to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification system in terms of the typical clinical presentation, neuroimaging profile, and vascular and cardiac evaluation 3. patients who were after 14 days of stroke onset and with stable clinical status.
Exclusion criteria
1. patients with rheumatic heart disease or history of heart valve surgery; 2. patients with acute coronary syndrome or percutaneous coronary intervention within 30 days previous to enrollment; 3. patients with active infective endocarditis; 4. patients with purpura disease or blood coagulation disorder; 5. patients who had active bleeding or the tendency to bleed; 6. patients with history of intracranial hemorrhage (ICH) or other serious bleeding events; 7. patients diagnosed with peptic ulcer disease within 30 days previous to enrollment; 8. patients who had esophageal varices; 9. patients who had trauma or major surgery within 30 days previous to enrollment or patients who planned to have major surgery; 10. patients with persistent blood pressure of 180/100mmHg or greater with or without anti-hypertension treatment; 11. patients who need chronic anticoagulant treatment due to disorders other than AF; 12. patients with severe liver and kidney dysfunction; 13. patients who were allergic to warfarin, aspirin or hirudin; 14. female patients who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy outcome event: the recurrence of cardioembolic stroke | One year after stroke onset | To compare the recurrence of cardioembolic stroke in hirudin plus aspirin group and the warfarin group. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety outcome events | One year after stroke onset | Intracranial hemorrhage and other bleeding events, any death and other serious adverse events |
Countries
China
Outcome results
None listed