D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy (DIRECT)

Wuhan Asia Heart Hospital

Status: Completed

Conditions: Atrial Fibrillation; Strokes Thrombotic

Treatments: Drug: Dabigatran Etexilate 110mg; Drug: Warfarin Sodium

Study type: Observational

Funder types: Other

Identifiers

NCT03280641

2015-P-016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,194 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,194 participants in 2 patient groups

Dabigatran Group

Description:

Patiets with atrial fibrillation received dabigatran (110mg, bid).

Treatment:

Drug: Dabigatran Etexilate 110mg

Warfarin Group

Description:

Patiets with atrial fibrillation received warfarin (110mg, bid).The target international normalized ratio (INR):1.6-3.0

Treatment:

Drug: Warfarin Sodium