NCT02646267

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

• Atrial Fibrillation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-01-01
• Completion: 2018-08-01
• First posted: 2016-01-05
• Last updated: 2016-01-05

Locations

1 site across 1 country: China