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Trial record 87 of 295 for:    warfarin AND anticoagulation

D-dimer to Guide Anticoagulation Therapy in Patients With Atrial Fibrillation (DATA-AF)

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: NCT03261284
Recruitment Status : Enrolling by invitation
First Posted : August 24, 2017
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Wuhan Asia Heart Hospital

Tracking Information
First Submitted Date  ICMJE August 22, 2017
First Posted Date  ICMJE August 24, 2017
Last Update Posted Date March 7, 2019
Estimated Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2017)
  • Thrombotic events [ Time Frame: 24 months ]
    Stroke, DVT, PE, Peripheral arterial embolism, ACS etc.
  • hemorrhagic events [ Time Frame: 24 months ]
    cerebral hemorrhage,Gastrointestinal bleeding etc.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03261284 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2017)
all-cause deaths [ Time Frame: 24 months ]
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 D-dimer to Guide Anticoagulation Therapy in Patients With Atrial Fibrillation
Official Title  ICMJE D-dimer to Determine Intensity of Anticoagulation to Reduce Clinical Outcomes in Patients With Atrial Fibrillation
Brief Summary This was a prospective, three arms, randomized controlled study.
Detailed Description D-dimer testing is performed in AF Patients receiving warfarin therapy (target INR:1.5-2.5) in Wuhan Asia Heart Hospital. Patients with elevated d-dimer levels (>0.5ug/ml FEU) were SCREENED AND RANDOMIZED to three groups at a ratio of 1:1:1. First, NOAC group,the anticoagulant was switched to Dabigatran (110mg,bid) when elevated d-dimer level was detected during warfarin therapy.Second,Higher-INR group, INR was adjusted to higher level (INR:2.0-3.0) when elevated d-dimer level was detected during warfarin therapy. Third, control group, patients with elevated d-dimer levels have no change in warfarin therapy. Warfarin is monitored once a month by INR ,and dabigatran dose not need monitor. All patients were followed up for 24 months until the occurrence of endpoints, including bleeding events, thrombotic events and all-cause deaths.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Thrombosis
  • Hemorrhage
  • Anticoagulant Adverse Reaction
Intervention  ICMJE
  • Drug: Dabigatran Etexilate 150 MG [Pradaxa]
    Dabigatran Etexilate 150mg,bid
    Other Name: Pradaxa
  • Drug: Warfarin Pill
    Add warfarin dose according to INR values.
Study Arms  ICMJE
  • Experimental: DOAC group
    Patients with elevated d-dimer levels was switched to DOAC (dabigatran 150mg, bid).
    Intervention: Drug: Dabigatran Etexilate 150 MG [Pradaxa]
  • Experimental: Higher-INR group
    Patients' target INR was adjusted from 1.5-2.5 to 2.0-3.0 by adding warfarin dose.
    Intervention: Drug: Warfarin Pill
  • No Intervention: Control group
    Patients continue previous strategy without change.
Publications * Not Provided

*   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 Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: August 23, 2017)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with non-valvular atrial fibrillation
  • Receiving warfarin therapy

Exclusion Criteria:

  • Patients who had suffered from recent (within 3 months) myocardial infarction, ischemic stroke, deep vein thrombosis, cerebral hemorrhages, or other serious diseases.
  • Those who had difficulty in compliance or were unavailable for follow-up.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (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 NCT03261284
Other Study ID Numbers  ICMJE 2017-P-032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wuhan Asia Heart Hospital
Study Sponsor  ICMJE Wuhan Asia Heart Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Zhenlu ZHANG, MD,PhD Wuhan Asia Heart Hospital
PRS Account Wuhan Asia Heart Hospital
Verification Date March 2019

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