D-dimer In Patients With atRial Fibrillation rEceiving an... | NCT03280641

Studies
D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy

NCT03280641

Sponsor

Wuhan Asia Heart Hospital

Status

Completed

Last Update Posted

Sep 12, 2017Actual

Enrollment

1,194Actual

Phase

Not provided

Conditions

Atrial Fibrillation
Strokes Thrombotic

Interventions

Dabigatran Etexilate 110mg
Warfarin Sodium

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 9, 2015Actual

Primary Completion Date

Jul 30, 2017Actual

Completion Date

Sep 1, 2017Actual

First Submitted Date

Sep 10, 2017

First Submission Date that Met QC Criteria

Sep 10, 2017

First Posted Date

Sep 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2017

Last Update Posted Date

Sep 12, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,194Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Dabigatran Etexilate 110mg	Drug	Dabigatran Etexilate 110mg, BID	Dabigatran Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiovascular events	Thrombotic events, cardiovascular deaths, major bleeding events	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Litao ZHANG, MD	Wuhan Asia Heart Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
WAHH		Wuhan	Hubei	430000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

We will share the IPD after the paper being published

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D000083244	Thrombotic Stroke

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069604	Dabigatran
D014859	Warfarin

Ancestor Terms

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles

Browse Leaves

Not provided

Browse Branches

Not provided