Analysis of the Potential Savings of Rivaroxaban Events Versus Vitamin K Antagonists Events
Estimate of Costs Associated With Atrial Fibrillation Treatment With Rivaroxaban Versus Vitamin K Antagonists
1 other identifier
observational
249
1 country
1
Brief Summary
The main objective of this project is to evaluate savings in direct costs as regards the use of rivaroxaban versus vitamin K antagonists (VKAs) in routine clinical practice using data from three cohorts of patients receiving VKAs or rivaroxaban in Spain, including the time in therapeutic range (TTR) values of the same and the incidence of events in the first year following diagnosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 26, 2018
CompletedFirst Posted
Study publicly available on registry
March 12, 2018
CompletedMarch 12, 2018
March 1, 2018
11 months
February 26, 2018
March 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Time in therapeutic range (TTR) values in the last 6 months
6 months
Presence of stroke
Presence of stroke prior and subsequent to treatment
12 months
Active substance received
Rivaroxaban or VKAs (Acenocoumarol and Warfarin)
12 months
Secondary Outcomes (5)
Date of stroke
12 months
Type of stroke
12 months
Duration of treatment (in days)
12 months
Dose of the prescribed treatment
12 months
Frequency of the prescribed treatment (in hours)
12 months
Other Outcomes (2)
Date of AF diagnosis
12 months
Comorbidities
12 months
Study Arms (2)
Treatment group with Rivaroxaban
Patients treated with Rivaroxaban
Control group with VKAs
Patients treated with VKAs. This control group will be subsequently divided based on the TTR value in the last 6 months (below 65% and above 65%).
Interventions
As prescribed by treating physicians
As prescribed by treating physicians. VKAs are Acenocoumarol and Warfarin.
Eligibility Criteria
Selected population will include records registered in electronic databases of patients diagnosed with nonvalvular AF, receiving treatment with VKAs or rivaroxaban for one year.
You may qualify if:
- Older than 18 years
- Diagnosis of non-valvular AF (ICD code 427.31)
- Pharmacological treatment with VKAs or rivaroxaban following diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (1)
Unknown Facility
Granada, Spain
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 26, 2018
First Posted
March 12, 2018
Study Start
June 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
March 12, 2018
Record last verified: 2018-03