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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
standard intensity warfarin
low intensity warfarin
dabigatran etexilate
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Dabigatran, Warfarin, Anticoagulation, Elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

standard intensity warfarin group

low intensity warfarin group

dabigatran etexilate group

Arm 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 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)

110mg dabigatran etexilate was administrated twice a day

Outcomes

Primary Outcome Measures

ischaemic stroke
ischaemic stroke was defined as a blockage in an artery that supplies blood to the brain , resulting in a deficiency in blood flow and focal neurological deficit lasting >24 hours.
major haemorrhage
Major haemorrhage was defined as intracranial hemorrhage, gastrointestinal bleeding, bleeding requiring hospitalization and surgical intervention, a reduction of hemoglobin by≥2 g/dL, requiring red blood cells transfusion ≥2 units.

Secondary Outcome Measures

minor bleeding
myocardial infarction
pulmonary embolism
cardiovascular death
all-cause mortality

Full Information

First Posted
January 3, 2016
Last Updated
January 4, 2016
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02646267
Brief Title
The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Dabigatran, Warfarin, Anticoagulation, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard intensity warfarin group
Arm Type
Experimental
Arm 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)
Arm Title
low intensity warfarin group
Arm Type
Experimental
Arm 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)
Arm Title
dabigatran etexilate group
Arm Type
Active Comparator
Arm Description
110mg dabigatran etexilate was administrated twice a day
Intervention Type
Drug
Intervention Name(s)
standard intensity warfarin
Intervention Description
target international normalised ratio(INR) was 2.1-3.0
Intervention Type
Drug
Intervention Name(s)
low intensity warfarin
Intervention Description
target international normalised ratio(INR) was 1.7-2.2
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate
Intervention Description
110mg, twice a day, oral
Primary Outcome Measure Information:
Title
ischaemic stroke
Description
ischaemic stroke was defined as a blockage in an artery that supplies blood to the brain , resulting in a deficiency in blood flow and focal neurological deficit lasting >24 hours.
Time Frame
2 years
Title
major haemorrhage
Description
Major haemorrhage was defined as intracranial hemorrhage, gastrointestinal bleeding, bleeding requiring hospitalization and surgical intervention, a reduction of hemoglobin by≥2 g/dL, requiring red blood cells transfusion ≥2 units.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
minor bleeding
Time Frame
2 years
Title
myocardial infarction
Time Frame
2 years
Title
pulmonary embolism
Time Frame
2 years
Title
cardiovascular death
Time Frame
2 years
Title
all-cause mortality
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of atrial fibrillation Echocardiography confirmed a non-valvular heart disease Age≥60 years Exclusion Criteria: Unable to cooperate with doctors CHA2DS2-VASc<2 Life expectancy of less than 1 year Rheumatic heart disease or dilated cardiomyopathy History of artificial valve replacement surgery Infectious endocarditis Stroke or transient ischemic attack(TIA) within the last 6 months Previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding Previous intolerance/allergy to warfarin or dabigatran etexilate Blood pressure greater than 180/110 mmHg Chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times Chronic renal failure, serum creatinine clearance rate (Ccr) less than 30 ml / min Patient was receiving antiplatelet or anticoagulant therapy due to other reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu Jun, doctor
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23200268
Citation
Wu J, Wang J, Jiang S, Xu J, Di Q, Zhou C, Min X, Pang S, Wang H, Xu D, Guo Y. The efficacy and safety of low intensity warfarin therapy in Chinese elderly atrial fibrillation patients with high CHADS2 risk score. Int J Cardiol. 2013 Sep 10;167(6):3067-8. doi: 10.1016/j.ijcard.2012.11.078. Epub 2012 Nov 28. No abstract available.
Results Reference
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The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation Patients

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