The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation Patients
NCT02646267 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210
Last updated 2016-01-05
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.
Conditions
Interventions
- DRUG
-
standard intensity warfarin
target international normalised ratio(INR) was 2.1-3.0
- DRUG
-
low intensity warfarin
target international normalised ratio(INR) was 1.7-2.2
- DRUG
-
dabigatran etexilate
110mg, twice a day, oral
Sponsors & Collaborators
-
The First Affiliated Hospital with Nanjing Medical University
lead OTHER
Principal Investigators
-
Wu Jun, doctor · The First Affiliated Hospital with Nanjing Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-31
- Primary Completion
- 2018-01-31
- Completion
- 2018-08-31
Countries
- China
Study Locations
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