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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03462446
Enrollment
249
Registered
2018-03-12
Start date
2015-06-01
Completion date
2016-05-01
Last updated
2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, VKA, Stroke

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.

Interventions

DRUGRivaroxaban (Xarelto, BAY59-7939)

As prescribed by treating physicians

As prescribed by treating physicians. VKAs are Acenocoumarol and Warfarin.

Sponsors

Janssen Research & Development, LLC
CollaboratorINDUSTRY
Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Older than 18 years * Diagnosis of non-valvular AF (ICD code 427.31) * Pharmacological treatment with VKAs or rivaroxaban following diagnosis

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Presence of stroke12 monthsPresence of stroke prior and subsequent to treatment
Active substance received12 monthsRivaroxaban or VKAs (Acenocoumarol and Warfarin)
Time in therapeutic range (TTR) values in the last 6 months6 months

Secondary

MeasureTime frameDescription
Duration of treatment (in days)12 months
Frequency of the prescribed treatment (in hours)12 months
Dose of the prescribed treatment12 months
Date of stroke12 months
Type of stroke12 monthsType of stroke acccording to patients group: unknown, haemorrhagic or ischaemic.

Other

MeasureTime frame
Date of AF diagnosis12 months
Comorbidities12 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026