Real-world Dosing Patterns of Rivaroxaban in the United States
2 other identifiers
observational
12,507
1 country
1
Brief Summary
The primary objective is to assess the proportion of Non-valvular atrial fibrillation (NVAF) patients receiving the standard dose of 20 mg of rivaroxaban or the reduced dose of 15 mg of rivaroxaban. The secondary objective is to determine if dosing patterns for rivaroxaban may be influenced by baseline chronic kidney disease (CKD) status (as a proxy for measured baseline renal function).
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
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
CompletedFirst Submitted
Initial submission to the registry
July 26, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedJune 28, 2023
August 1, 2017
18 days
July 26, 2017
June 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of NVAF patients receiving 20 mg Rivaroxaban
At baseline
Number of NVAF patients receiving 15 mg Rivaroxaban
At baseline
Secondary Outcomes (1)
Baseline renal function
At baseline
Study Arms (2)
NVAF patients receiving 20 mg rivaroxaban
NVAF patients who receive a standard dose of rivaroxaban (20 mg daily)
NVAF patients receiving 15 mg rivaroxaban
NVAF patients who receive a reduced dose of rivaroxaban (15 mg daily)
Interventions
As prescribed by treating physicians
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
- Evidence of continuous enrollment in MarketScan during 180 days before the date of the first prescription of rivaroxaban
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 VTE (Venous thromboembolism), pulmonary embolism or DVT (Deep Vein Thrombosis)
- Patients with major surgery defined as hip or knee replacement
- Prescriptions of OACs (Oral anticoagulants) (apixaban,warfarin, dabigatran, rivaroxaban) before index date
- Prescription of more than one OAC on the index date
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
July 26, 2017
First Posted
August 8, 2017
Study Start
February 12, 2016
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
June 28, 2023
Record last verified: 2017-08