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CompletedNCT03280641DIRECTUpdated Sep 12, 2017

D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy

An observational study in Atrial Fibrillation and Strokes Thrombotic, sponsored by Wuhan Asia Heart Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-09-12.

Sponsored by Wuhan Asia Heart Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,194
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation
  • Strokes Thrombotic
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with Non-valvular atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.

Inclusion criteria

  • Non-valvular atrial fibrillation
  • Receiving oral anticoagulation therapy and have good compliance

Exclusion criteria

Exclusion Criteria:

  • Life expectancy less than 1 year
  • Thrombosis or major bleeding history within 3 months
  • Refusal to Participate
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,194 participants (actual)
Patient registry
No

Groups and cohorts

  • Dabigatran Group

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

    Drug: Dabigatran Etexilate 110mg

  • Warfarin Group

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

    Drug: Warfarin Sodium

Interventions

  • DrugDabigatran Etexilate 110mg

    Dabigatran Etexilate 110mg, BID

    Also known as: Pradaxa

  • DrugWarfarin Sodium

    Target INR:1.6-3.0

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What researchers measure

Primary outcomes

  1. Cardiovascular events

    Thrombotic events, cardiovascular deaths, major bleeding events

    Time frame: 12 months

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Study locations

1 site
  • WAHH
    Wuhan, Hubei 430000, China
07

References and documents

Individual participant data

Plan to share: Undecided — We will share the IPD after the paper being published

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03280641
Lead sponsor
Wuhan Asia Heart Hospital
Responsible party
Sponsor
First posted
Sep 12, 2017
Start date
Aug 9, 2015
Primary completion
Jul 30, 2017
Completion
Sep 1, 2017
Last update
Sep 12, 2017

Study contacts

Litao ZHANG, MD
principal investigator · Wuhan Asia Heart Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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