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D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy (DIRECT)

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: NCT03280641
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Wuhan Asia Heart Hospital

Study Description
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Brief Summary:
This is a sigle-center, prospective study to evaluate the role of D-Dimer testing in patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.

Condition or disease Intervention/treatment
Atrial Fibrillation Strokes Thrombotic Drug: Dabigatran Etexilate 110mg Drug: Warfarin Sodium

Detailed Description:
Patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy was screened and signed to two group: Dabigatran group and Warfarin group. D-dimer test was analyzed before and 3 months after anticoagulation starting specificly. Patients were followed-up for at least 12 months,and clinical outcomes, including thrombotic events major bleeding events and all-cause deaths were recorded during follow-up period.
Study Design
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Study Type : Observational
Actual Enrollment : 1194 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of D-dimer in Patients With Atrial Fibrillation Receiving Anticoagulation Therapy
Actual Study Start Date : August 9, 2015
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Dabigatran Group
Patiets with atrial fibrillation received dabigatran (110mg, bid).
 Drug: Dabigatran Etexilate 110mg
Dabigatran Etexilate 110mg, BID
Other Name: Pradaxa
Warfarin Group
Patiets with atrial fibrillation received warfarin (110mg, bid).The target international normalized ratio (INR):1.6-3.0
 Drug: Warfarin Sodium
Target INR:1.6-3.0


Outcome Measures
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Primary Outcome Measures :
  1. Cardiovascular events [ Time Frame: 12 months ]
    Thrombotic events, cardiovascular deaths, major bleeding events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with Non-valvular atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.
Criteria

Inclusion Criteria:

  • Non-valvular atrial fibrillation
  • Receiving oral anticoagulation therapy and have good compliance

Exclusion Criteria:

  • Life expectancy less than 1 year
  • Thrombosis or major bleeding history within 3 months
  • Refusal to Participate
Contacts and Locations
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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): NCT03280641


Locations
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China, Hubei
WAHH
Wuhan, Hubei, China, 430000
Sponsors and Collaborators
Wuhan Asia Heart Hospital
Investigators
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Principal Investigator: Litao ZHANG, MD Wuhan Asia Heart Hospital
More Information
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Responsible Party: Wuhan Asia Heart Hospital
ClinicalTrials.gov Identifier: NCT03280641    
Other Study ID Numbers: 2015-P-016
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will share the IPD after the paper being published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombotic Stroke
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ischemic Stroke
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Warfarin
Dabigatran
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action