Real-world Comparative Effectiveness of Rivaroxaban Versus VKA

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: VKA (Vitamin K antagonist)

• Registration Number: NCT02690155
• Lead Sponsor: Bayer

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-12
• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-24
• Primary Completion: 2016-03-01
• Study Completion: 2016-03-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38831

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban (Xarelto, BAY59-7939)	NVAF patients who were initiated on rivaroxaban for stroke prevention
VKA (Vitamin K antagonist)	VKA (Vitamin K antagonist)	NVAF patients who were initiated on VKA for stroke prevention

Primary Outcome Measures

Name	Time	Method
Incidence of Hospitalization Events (composite endpoint)	Within 2 years of starting treatment