D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy

Atrial Fibrillation Clinical Trial

— DIRECT  

Official title:

The Role of D-dimer in Patients With Atrial Fibrillation Receiving Anticoagulation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280641
• Other study ID #: 2015-P-016
• Status: Completed
• Phase: N/A
• First received: September 10, 2017
• Last updated: September 10, 2017
• Start date: August 9, 2015
• Est. completion date: September 1, 2017

Study information

• Verified date: September 2017
• Source: Wuhan Asia Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1194
• Est. completion date: September 1, 2017
• Est. primary completion date: July 30, 2017
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Strokes Thrombotic

Intervention

Drug:
• Dabigatran Etexilate 110mg
Dabigatran Etexilate 110mg, BID
• Warfarin Sodium
Target INR:1.6-3.0

Locations

Country	Name	City	State
China	WAHH	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Asia Heart Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular events	Thrombotic events, cardiovascular deaths, major bleeding events	12 months