Real-world Comparative Effectiveness of Apixaban Versus Vitamin K Antagonist
Completed
Conditions studied: Atrial Fibrillation
In brief
To obtain a better understanding on the comparative effectiveness of apixaban versus VKA (Vitamin K antagonist) for stroke prevention in patients with NVAF (Non-valvular atrial fibrillation) in a real-life setting.
Key facts
- Study ID
- NCT02687854
- Run by
- Bayer
- People needed
- 18591
- 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…
- NVAF will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 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 (C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years; D: 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 apixaban use baseline period
You may not qualify if…
- Patients <18 years of age
- Patients with valvular AF (Atrial fibrillation)
- Pregnancy
- Malignant cancers
- Transient cause of AF
- Patients with VTE (Venous thromboembolism) (pulmonary embolism or DVT (Deep Vein Thrombosis))
- Patients with major surgery defined as hip or knee replacement
- Prescriptions of OACs (Oral anticoagulants) (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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