NCT03280641

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,194

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

September 10, 2017

Last Update Submit

September 10, 2017

Conditions

Atrial FibrillationStrokes Thrombotic

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular events

    Thrombotic events, cardiovascular deaths, major bleeding events

    12 months

Study Arms (2)

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

Dabigatran Etexilate 110mgDRUG

Dabigatran Etexilate 110mg, BID

Also known as: Pradaxa
Dabigatran Group
Warfarin SodiumDRUG

Target INR:1.6-3.0

Warfarin Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WAHH

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Atrial FibrillationThrombotic Stroke

Interventions

DabigatranWarfarin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemic StrokeStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring4-HydroxycoumarinsCoumarinsBenzopyransPyrans

Study Officials

  • Litao ZHANG, MD

    Wuhan Asia Heart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2017

First Posted

September 12, 2017

Study Start

August 9, 2015

Primary Completion

July 30, 2017

Study Completion

September 1, 2017

Last Updated

September 12, 2017

Record last verified: 2017-09

Locations

CN(1)