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Clinical trial

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

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Last updated:1st Mar 2016

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.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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
Estimated Enrollment: 210
Study Start Date: March 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
standard intensity warfarin group
- Experimental: low intensity warfarin group
- Active Comparator: dabigatran etexilate group

Category Value
Study start date 2016-03-01

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