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

Study Description

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.

Study Design

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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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

Drug Information available for: Warfarin Dabigatran Dabigatran etexilate Dabigatran etexilate mesylate

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

all-cause deaths [ Time Frame: 24 months ]

Eligibility Criteria

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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.

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): 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

More Information

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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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Atrial Fibrillation Thrombosis Hemorrhage Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Embolism and Thrombosis Vascular Diseases Warfarin 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

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