D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy (DIRECT)

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Strokes Thrombotic
• Intervention / Treatment: Drug: Dabigatran Etexilate 110mg; Drug: Warfarin Sodium

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.

• Study Type: Observational
• Enrollment (Actual): 1194

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • WAHH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dabigatran Group; Patiets with atrial fibrillation received dabigatran (110mg, bid).	Drug: Dabigatran Etexilate 110mg; Dabigatran Etexilate 110mg, BID; Other Names: Pradaxa
Warfarin Group; Patiets with atrial fibrillation received warfarin (110mg, bid).The target international normalized ratio (INR):1.6-3.0	Drug: Warfarin Sodium; Target INR:1.6-3.0

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wuhan Asia Heart Hospital
• Investigators: Principal Investigator: Litao ZHANG, MD, Wuhan Asia Heart Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 9, 2015
• Primary Completion (ACTUAL): July 30, 2017
• Study Completion (ACTUAL): September 1, 2017

Study Registration Dates

• First Submitted: September 10, 2017
• First Submitted That Met QC Criteria: September 10, 2017
• First Posted (ACTUAL): September 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 10, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Ischemic Stroke; Atrial Fibrillation; Thrombotic Stroke; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Dabigatran; Warfarin
• Other Study ID Numbers: 2015-P-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will share the IPD after the paper being published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No