The Secondary Prevention of patients with an initial cardioembolic stroke associated with nonvalvular atrial fibrillation.
For the patients with stroke associated with atrial fibrillation,the guidelines recommend warfarin as the secondary prevention,but it's disadvantages such as the narrow safety scope,high bleeding risk hinder it's utilization in clinical.We divide our trial into two groups, the experimental group is aspirin plus Hirudin,the control group is warfarin.We aim at comparing two groups'efficacy and safety difference in secondary prevention of atrial fibrillation combined stroke.
- Warfarin (Coumadin®)Drug
Intervention Desc: An initial dose of Warfarin is 1.5mg,once daily. 3 days later,we check the international normalized ratio(INR) values and adjust the warfarin dose make INR between 2-3 steady.Then, we maintain this warfarin dose. ARM 1: Kind: Experimental Label: Warfarin Description: Warfarin group was given 14-21 days after the onset of oral warfarin, an initial dose of 1.5mg, 1 day, 3 days to check international normalized ratio values, warfarin dosage adjustments until international normalized ratio stable in the 2.0-3.0 range, and thereafter maintain this dose, monthly review of international normalized ratio, adjust the dosage.
- Aspirin and hirudin Drug
Other Names: aspirin and hirudin Intervention Desc: hirudin capsules every two, three times a day, every aspirin 100mg, once daily. ARM 1: Kind: Experimental Label: aspirin and hirudin Description: In the aspirin and hirudin treatment group 14-21 days after the onset of hirudin given aspirin enteric-coated tablets and capsules for oral, hirudin capsules every two, three times a day, every aspirin 100mg, once daily.
- Aspirin plus hirudin Drug
Other Names: aspirin plus hirudin Intervention Desc: hirudin two tables, three times a day and aspirin 100mg, once daily. ARM 1: Kind: Experimental Label: aspirin plus hirudin Description: 14 days after stroke occurred, the experimental group gives hirudin two tables three times a day and aspirin 100mg, once daily.
- Allocation: Non-Randomized
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||The recurrence of cardioembolic stroke||up to one year after onset||No|
|Secondary||Other ischemic cerebrovascular disease||one year after onset||No|