Trial Condition(s):

Atrial Fibrillation

Real-world comparative effectiveness of Dabigatran versus Vitamin K antagonist (DABI-F)

Bayer Identifier:

18732

ClinicalTrials.gov Identifier:

NCT02687867

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
56039
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
No Drug
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

New York, United States

Status
Active, not recruiting
 

Trial Design