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OpenTrials
Completed

NCT Number: NCT03280641

D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dabigatran Etexilate 110mg

Drug

Dabigatran Etexilate 110mg, BID

Other names: Pradaxa

Warfarin sodium

Drug

Target INR:1.6-3.0

Primary outcomes

  1. Cardiovascular events

    Time frame: 12 months

    Thrombotic events, cardiovascular deaths, major bleeding events

Sponsors and collaborators

Lead sponsor

Wuhan Asia Heart Hospital

Other

Registry information

Official study title

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

Acronym: DIRECT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2017
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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