Real-world Comparative Effectiveness of Rivaroxaban Versus VKA

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Treatments: Rivaroxaban; Vitamin K; Vitamins

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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