Real-world Comparative Effectiveness of Rivaroxaban Versus VKA
RIVA-F
1 other identifier
observational
38,831
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 12, 2016
CompletedFirst Submitted
Initial submission to the registry
February 19, 2016
CompletedFirst Posted
Study publicly available on registry
February 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 5, 2017
April 1, 2017
18 days
February 19, 2016
April 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Hospitalization Events (composite endpoint)
Within 2 years of starting treatment
Study Arms (2)
Rivaroxaban
NVAF patients who were initiated on rivaroxaban for stroke prevention
VKA (Vitamin K antagonist)
NVAF patients who were initiated on VKA for stroke prevention
Interventions
Eligibility Criteria
Patients with non-valvular atrial fibrillation (NVAF)
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (1)
Unknown Facility
New York, New York, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2016
First Posted
February 24, 2016
Study Start
February 12, 2016
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 5, 2017
Record last verified: 2017-04