D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy

Completed

• Conditions: Strokes Thrombotic; Atrial Fibrillation
• Interventions: Drug: Dabigatran Etexilate 110mg; Drug: Warfarin Sodium

• Registration Number: NCT03280641
• Lead Sponsor: Wuhan Asia Heart Hospital

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.

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 Timeline

• Study Start: 2015-08-09
• Primary Completion: 2017-07-30
• Status Verified: 2017-09
• Study Completion: 2017-09-01
• Study First Submitted: 2017-09-10
• Study First Submitted QC: 2017-09-10
• Last Update Submitted: 2017-09-10
• Study First Posted: 2017-09-12
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1194

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dabigatran Group	Dabigatran Etexilate 110mg	Patiets with atrial fibrillation received dabigatran (110mg, bid).
Warfarin Group	Warfarin Sodium	Patiets with atrial fibrillation received warfarin (110mg, bid).The target international normalized ratio (INR):1.6-3.0

Primary Outcome Measures

Name	Time	Method
Cardiovascular events	12 months	Thrombotic events, cardiovascular deaths, major bleeding events

Trial Locations

Locations (1)

WAHH; 🇨🇳 Wuhan, Hubei, China