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
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Thrombosis Hemorrhage Anticoagulant Adverse Reaction||Drug: Dabigatran Etexilate 150 MG [Pradaxa] Drug: Warfarin Pill||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- all-cause deaths [ Time Frame: 24 months ]
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
|Wuhan, Hubei, China, 430022|
|Study Director:||Zhenlu ZHANG, MD,PhD||Wuhan Asia Heart Hospital|