Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist

Atrial Fibrillation Clinical Trial

— DABI-F  

Official title:

Real-world Comparative Effectiveness of Dabigatran Versus VKA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687867
• Other study ID #: 18732
• Secondary ID: NN1513US
• Status: Completed
• Phase: N/A
• First received: February 17, 2016
• Last updated: April 4, 2017
• Start date: February 12, 2016
• Est. completion date: March 1, 2016

Study information

• Verified date: April 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To obtain a better understanding on the comparative effectiveness of dabigatran versus Vitamin K antagonist (VKA) for stroke prevention in patients with Non-valvular atrial fibrillation (NVAF) in a real-life setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56039
• Est. completion date: March 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non-valvular atrial fibrillation will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 (International Classification of Disease, Ninth Revision, Clinical Modification) as the diagnosis code at any time in the patient's data history prior to inclusion

• Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics

• CHA2DS2-Vasc (Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V:

Vascular disease; A: Age 65-74 years; Sc: Sex category ) score =2 during the 180 days prior to index dabigatran use baseline period

Exclusion Criteria:

• Patients <18 years of age

• Patients with valvular Atrial fibrillation

• Pregnancy

• Malignant cancers

• Transient cause of Atrial fibrillation

• Patients with Venous thromboembolism (pulmonary embolism or Deep Vein Thrombosis)

• Patients with major surgery defined as hip or knee replacement

• Prescriptions of Oral anticoagulants (OACs) {apixaban, warfarin, dabigatran, rivaroxaban} before index date

• Prescription of more than one OAC on the index date

• Patient with any of the events defined in the composite endpoint

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Dabigatran (Pradaxa)
As prescribed by treating physicians
• Vitamin K antagonist
As prescribed by treating physicians

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Hospitalization Events (composite endpoint)		Within 2 years of starting treatment

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