Analysis of the Potential Savings of Rivaroxaban Events Versus Vitamin K Antagonists Events

Atrial Fibrillation Clinical Trial

Official title:

Estimate of Costs Associated With Atrial Fibrillation Treatment With Rivaroxaban Versus Vitamin K Antagonists

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462446
• Other study ID #: 18231
• Status: Completed
• Phase: N/A
• First received: February 26, 2018
• Last updated: March 9, 2018
• Start date: June 1, 2015
• Est. completion date: May 1, 2016

Study information

• Verified date: March 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: May 1, 2016
• Est. primary completion date: May 1, 2016
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by treating physicians
• Vitamin K antagonists (VKAs)
As prescribed by treating physicians. VKAs are Acenocoumarol and Warfarin.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Date of AF diagnosis		12 months
Other	Comorbidities		12 months
Primary	Time in therapeutic range (TTR) values in the last 6 months		6 months
Primary	Presence of stroke	Presence of stroke prior and subsequent to treatment	12 months
Primary	Active substance received	Rivaroxaban or VKAs (Acenocoumarol and Warfarin)	12 months
Secondary	Date of stroke		12 months
Secondary	Type of stroke	Type of stroke acccording to patients group: unknown, haemorrhagic or ischaemic.	12 months
Secondary	Duration of treatment (in days)		12 months
Secondary	Dose of the prescribed treatment		12 months
Secondary	Frequency of the prescribed treatment (in hours)		12 months

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