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Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist (DABI-F)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02687867
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : April 5, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Dabigatran (Pradaxa) Drug: Vitamin K antagonist

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Study Type : Observational
Actual Enrollment : 56039 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-world Comparative Effectiveness of Dabigatran Versus VKA
Actual Study Start Date : February 12, 2016
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : March 1, 2016

Group/Cohort Intervention/treatment
Non-valvular atrial fibrillation patients who were initiated on dabigatran for stroke prevention.
Drug: Dabigatran (Pradaxa)
As prescribed by treating physicians

Vitamin K antagonist
Non-valvular atrial fibrillation patients who were initiated on VKA for stroke prevention.
Drug: Vitamin K antagonist
As prescribed by treating physicians
Other Name: As prescribed by treating physicians

Primary Outcome Measures :
  1. Incidence of Hospitalization Events (composite endpoint) [ Time Frame: Within 2 years of starting treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-valvular atrial fibrillation (NVAF).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02687867

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United States, New York
New York, New York, United States
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer Identifier: NCT02687867     History of Changes
Other Study ID Numbers: 18732
NN1513US ( Other Identifier: Company Internal )
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Keywords provided by Bayer:
Non-valvular atrial fibrillation (NVAF)
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vitamin K
Growth Substances
Physiological Effects of Drugs
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents