ClinicalTrials.gg
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

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's enrollment of 1,194 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Wuhan Asia Heart Hospital is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • less than 1 year
  • Thrombosis or major bleeding history within 3 months
  • Refusal to Participate
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

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

06

What researchers measure

Primary outcomes

  1. Cardiovascular events

    Thrombotic events, cardiovascular deaths, major bleeding events

    Time frame: 12 months

07

Study locations

1 site
  • WAHH
    Wuhan, Hubei 430000, China
08

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2015 to primary completion in Jul 2017, 23 months.

Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's 23 months is below that.

Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2017
First posted
Sep 12, 2017
StartActual
Aug 9, 2015
Primary completionActual
Jul 30, 2017
CompletionActual
Sep 1, 2017
Last update
Sep 12, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

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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Discussion

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