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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02646267
Recruitment Status : Unknown
Verified January 2016 by The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : January 5, 2016
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: standard intensity warfarin Drug: low intensity warfarin Drug: dabigatran etexilate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: standard intensity warfarin group
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)
 Drug: standard intensity warfarin
target international normalised ratio(INR) was 2.1-3.0
Experimental: low intensity warfarin group
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)
 Drug: low intensity warfarin
target international normalised ratio(INR) was 1.7-2.2
Active Comparator: dabigatran etexilate group
110mg dabigatran etexilate was administrated twice a day
 Drug: dabigatran etexilate
110mg, twice a day, oral


Outcome Measures
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Primary Outcome Measures :
  1. ischaemic stroke [ Time Frame: 2 years ]
    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.

  2. major haemorrhage [ Time Frame: 2 years ]
    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 :
  1. minor bleeding [ Time Frame: 2 years ]
  2. myocardial infarction [ Time Frame: 2 years ]
  3. pulmonary embolism [ Time Frame: 2 years ]
  4. cardiovascular death [ Time Frame: 2 years ]
  5. all-cause mortality [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646267


Locations
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China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Principal Investigator: Wu Jun, doctor The First Affiliated Hospital with Nanjing Medical University
More Information
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Publications:

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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02646267    
Other Study ID Numbers: SEL102
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
Atrial fibrillation
Dabigatran
Warfarin
Anticoagulation
Elderly
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Dabigatran
 Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action