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

Sponsor

Wuhan Asia Heart Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03261284

Collaborator

(none)

600

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Feb 28, 2020

Anticipated Study Completion Date :

May 30, 2020

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 Names: 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.

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 Names:

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 [24 months]
Stroke, DVT, PE, Peripheral arterial embolism, ACS etc.
hemorrhagic events [24 months]
cerebral hemorrhage,Gastrointestinal bleeding etc.

Secondary Outcome Measures

all-cause deaths [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.