Real-world Comparative Effectiveness of Rivaroxaban Versus VKA

Completed

Conditions studied: Atrial Fibrillation

In brief

To obtain a better understanding on the comparative effectiveness of rivaroxaban 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

NCT02690155

Run by

Bayer

People needed

38831

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(non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD(International Classification of Disease)-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 score ≥2 during the 180 days prior to index rivaroxaban use baseline period (CHA2DS2-Vasc: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category)

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 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
• Fatal bleeding
• Fatal Stroke/Myocardial infarction
• Intracranial hemorrhage
• Ischemic stroke
• Myocardial infarction

Where it is running

• Study site — New York, New York, United States

Full record on ClinicalTrials.gov

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