Hirudin Plus Aspirin in the Secondary Prevention of Cardioembolic Stroke Due to Nonvalvular Atrial Fibrillation

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital
• Collaborators: 451 Hospital; Ankang Central Hospital; Baoji Central Hospital; Baoji People's Hospital; Central Hospital of China Railway 20th Bureau; First Affiliated Hospital Xi'an Jiaotong University; Hanzhong Central Hospital; Shaanxi people's Hospital; Shaanxi Provincial People's Hospital; Shangluo Central Hospital; Shangluo Second People's Hospital; Tang-Du Hospital; The Third Hospital of PLA; Xi'an Central Hospital; Xi'an Ninth Hospital; Xiangyang Central Hospital; Xianyang 215 hospital; Yan'an people's Hospital; Yan'an University Affiliated Hospital; Yulin Second Hospital
• Treatments: Aspirin; Hirudins; Warfarin

Criteria

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.