D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy

NCT ID: NCT03280641

Last Updated: 2017-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1194 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-09

Study Completion Date

2017-09-01

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Strokes Thrombotic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dabigatran Group

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

Dabigatran Etexilate 110mg

Intervention Type DRUG

Dabigatran Etexilate 110mg, BID

Warfarin Group

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

Warfarin Sodium

Intervention Type DRUG

Target INR:1.6-3.0

Interventions

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Dabigatran Etexilate 110mg

Dabigatran Etexilate 110mg, BID

Intervention Type DRUG

Warfarin Sodium

Target INR:1.6-3.0

Intervention Type DRUG

Other Intervention Names

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Pradaxa

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan Asia Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Litao ZHANG, MD

Role: PRINCIPAL_INVESTIGATOR

Wuhan Asia Heart Hospital

Locations

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WAHH

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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2015-P-016

Identifier Type: -

Identifier Source: org_study_id

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