The Role of D-dimer in Patients With Atrial Fibrillation Receiving Anticoagulation Therapy

D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy



Sponsors


Source

Wuhan Asia Heart Hospital

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Completed

Start Date

2015-08-09

Completion Date

2017-09-01

Primary Completion Date

2017-07-30

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

Cardiovascular events
12 months

Number Of Groups

2

Enrollment

1194

Conditions


Intervention

Intervention Type

Drug

Intervention Name


Description

Dabigatran Etexilate 110mg, BID

Arm Group Label

Dabigatran Group

Other Name

Pradaxa


Intervention Type

Drug

Intervention Name


Description

Target INR:1.6-3.0

Arm Group Label

Warfarin Group



Eligibility

Study Pop

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

Sampling Method

Non-Probability Sample

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

Gender

All

Minimum Age

18 Years

Maximum Age

75 Years


Overall Official

Last Name

Role

Affiliation

Litao ZHANG, MD
Principal Investigator
Wuhan Asia Heart Hospital

Location

Facility

WAHH
Wuhan Hubei 430000 China

Location Countries

Country

China


Verification Date

2017-09-01

Lastchanged Date

2017-09-10

Firstreceived Date

2017-09-10

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Intervention Browse

Mesh Term

Warfarin

Dabigatran

Fibrin fragment D



Arm Group

Arm Group Label

Dabigatran Group

Description

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


Arm Group Label

Warfarin Group

Description

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



Firstreceived Results Date

N/A

Acronym

DIRECT

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Prospective



ClinicalTrials.gov processed this data on September 12, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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