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Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist

Real-world Comparative Effectiveness of Dabigatran Versus VKA

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02687867
Acronym
DABI-F
Enrollment
56039
Registered
2016-02-22
Start date
2016-02-12
Completion date
2016-03-01
Last updated
2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Non-valvular atrial fibrillation (NVAF), Prevention, Stroke

Brief 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.

Interventions

As prescribed by treating physicians

As prescribed by treating physicians

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of Hospitalization Events (composite endpoint)Within 2 years of starting treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026