Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 30 of 232 for:    warfarin AND International

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

Tracking Information
First Submitted Date  ICMJE January 3, 2016
First Posted Date  ICMJE January 5, 2016
Last Update Posted Date January 5, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
  • minor bleeding [ Time Frame: 2 years ]
  • myocardial infarction [ Time Frame: 2 years ]
  • pulmonary embolism [ Time Frame: 2 years ]
  • cardiovascular death [ Time Frame: 2 years ]
  • all-cause mortality [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
    Intervention: Drug: standard intensity warfarin
  • 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)
    Intervention: Drug: low intensity warfarin
  • Active Comparator: dabigatran etexilate group
    110mg dabigatran etexilate was administrated twice a day
    Intervention: Drug: dabigatran etexilate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 4, 2016)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02646267
Other Study ID Numbers  ICMJE SEL102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The First Affiliated Hospital with Nanjing Medical University
Study Sponsor  ICMJE The First Affiliated Hospital with Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wu Jun, doctor The First Affiliated Hospital with Nanjing Medical University
PRS Account The First Affiliated Hospital with Nanjing Medical University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP