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OpenTrials
Completed

NCT Number: NCT02687867

Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dabigatran (Pradaxa)

Drug

As prescribed by treating physicians

Vitamin K antagonist

Drug

As prescribed by treating physicians

Other names: As prescribed by treating physicians

Primary outcomes

  1. Incidence of Hospitalization Events (composite endpoint)

    Time frame: Within 2 years of starting treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Real-world Comparative Effectiveness of Dabigatran Versus VKA

Acronym: DABI-F

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 22, 2016
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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