The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation Patients

• Status: Unknown status
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to demonstrate the efficacy and safety of dabigatran etexilate and different intensity warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Treatments: Dabigatran; Warfarin

Criteria

Inclusion Criteria:

1. Clinical diagnosis of atrial fibrillation

2. Echocardiography confirmed a non-valvular heart disease

3. Age≥60 years

Exclusion Criteria:

1. Unable to cooperate with doctors

2. CHA2DS2-VASc<2

3. Life expectancy of less than 1 year

4. Rheumatic heart disease or dilated cardiomyopathy

5. History of artificial valve replacement surgery

6. Infectious endocarditis

7. Stroke or transient ischemic attack(TIA) within the last 6 months

8. Previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding

9. Previous intolerance/allergy to warfarin or dabigatran etexilate

10. Blood pressure greater than 180/110 mmHg

11. Chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times

12. Chronic renal failure, serum creatinine clearance rate (Ccr) less than 30 ml / min

13. Patient was receiving antiplatelet or anticoagulant therapy due to other reasons