Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist

Completed

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID: NCT02687867
Run by: Bayer
People needed: 56039
Starts: 2016-02-12
Expected to finish: 2016-03-01
Last updated by the study team: 2017-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Study site — New York, New York, United States

Full record on ClinicalTrials.gov

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