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

Enrolling by invitation

Phase 4 Results N/A

Trial Description

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

  • Dabigatran etexilate Drug
    Intervention Desc: 110mg, twice a day, oral
    ARM 1: Kind: Experimental
    Label: dabigatran etexilate group
    Description: 110mg dabigatran etexilate was administrated twice a day
  • Standard intensity warfarin Drug
    Intervention Desc: target international normalised ratio(INR) was 2.1-3.0
    ARM 1: Kind: Experimental
    Label: standard intensity warfarin group
    Description: standard intensity warfarin group, target international normalised ratio(INR) was 2.1-3.0, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(2.1-3.0)
  • Low intensity warfarin Drug
    Intervention Desc: target international normalised ratio(INR) was 1.7-2.2
    ARM 1: Kind: Experimental
    Label: low intensity warfarin group
    Description: low intensity warfarin group, target international normalised ratio(INR) was 1.7-2.2, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(1.7-2.2)

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary ischaemic stroke 2 years No
Primary major haemorrhage 2 years Yes
Secondary minor bleeding 2 years Yes
Secondary myocardial infarction 2 years No
Secondary pulmonary embolism 2 years No
Secondary cardiovascular death 2 years No
Secondary all-cause mortality 2 years No

Sponsors