Real-world Comparative Effectiveness of Rivaroxaban Versus VKA

Atrial Fibrillation Clinical Trial

— RIVA-F  

Official title:

Real-world Comparative Effectiveness of Rivaroxaban Versus VKA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690155
• Other study ID #: 18734
• Status: Completed
• Phase: N/A
• First received: February 19, 2016
• Last updated: April 4, 2017
• Start date: February 12, 2016
• Est. completion date: March 1, 2016

Study information

• Verified date: April 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38831
• Est. completion date: March 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by treating physicians
• VKA (Vitamin K antagonist)
As prescribed by treating physicians

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Hospitalization Events (composite endpoint)		Within 2 years of starting treatment

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