An observational study in Cardioembolic Stroke and Atrial Fibrillation, sponsored by Xijing Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-21.
Sponsored by Xijing Hospital · Observational
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.
40 studies on the registry are indexed under Embolic Stroke; 11 are open to participants now.
This study's enrollment of 239 is below the median of 364 across 27 observational studies indexed under Embolic Stroke.
Browse Embolic Stroke studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
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Cardioembolic stroke patients due to nonvalvular atrialf ibrillation.
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Exclusion Criteria:
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.
Drug: hirudin plus aspirin
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.
Drug: Warfarin
Drug page: Aspirin
natural hirudin 0.75g, three times a day (Brand name: Maixuekang capsule, Guizhou Xinbang Pharmaceutical Co., China) and aspirin 100mg, once daily
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.
Efficacy outcome event: the recurrence of cardioembolic stroke
To compare the recurrence of cardioembolic stroke in hirudin plus aspirin group and the warfarin group.
Time frame: One year after stroke onset
Safety outcome events
Intracranial hemorrhage and other bleeding events, any death and other serious adverse events
Time frame: One year after stroke onset
The record gives a start of Jun 2014, a primary completion of Dec 2016 and a completion of Oct 2018. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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