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Trial record 87 of 291 for:    warfarin AND anticoagulation

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

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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

Brief Summary:
This was a prospective, three arms, randomized controlled study.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Thrombosis Hemorrhage Anticoagulant Adverse Reaction Drug: Dabigatran Etexilate 150 MG [Pradaxa] Drug: Warfarin Pill Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: D-dimer to Determine Intensity of Anticoagulation to Reduce Clinical Outcomes in Patients With Atrial Fibrillation
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : May 30, 2020


Arm Intervention/treatment
Experimental: DOAC group
Patients with elevated d-dimer levels was switched to DOAC (dabigatran 150mg, bid).
Drug: Dabigatran Etexilate 150 MG [Pradaxa]
Dabigatran Etexilate 150mg,bid
Other Name: Pradaxa

Experimental: Higher-INR group
Patients' target INR was adjusted from 1.5-2.5 to 2.0-3.0 by adding warfarin dose.
Drug: Warfarin Pill
Add warfarin dose according to INR values.

No Intervention: Control group
Patients continue previous strategy without change.



Primary Outcome Measures :
  1. Thrombotic events [ Time Frame: 24 months ]
    Stroke, DVT, PE, Peripheral arterial embolism, ACS etc.

  2. hemorrhagic events [ Time Frame: 24 months ]
    cerebral hemorrhage,Gastrointestinal bleeding etc.


Secondary Outcome Measures :
  1. all-cause deaths [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03261284


Locations
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China, Hubei
Zhang litao
Wuhan, Hubei, China, 430022
Sponsors and Collaborators
Wuhan Asia Heart Hospital
Investigators
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Study Director: Zhenlu ZHANG, MD,PhD Wuhan Asia Heart Hospital

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Responsible Party: Wuhan Asia Heart Hospital
ClinicalTrials.gov Identifier: NCT03261284     History of Changes
Other Study ID Numbers: 2017-P-032
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wuhan Asia Heart Hospital:
D-dimer
Nonvalvular atrial fibrillation
Direct thrombin inhibitor
INR
Additional relevant MeSH terms:
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Warfarin
Atrial Fibrillation
Thrombosis
Hemorrhage
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Dabigatran
Fibrin fragment D
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants