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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Vitamin K antagonists (VKAs)

• Registration Number: NCT03462446
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2016-05-01
• Study Completion: 2016-05-01
• Study First Submitted: 2018-02-26
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-09
• Last Update Submitted: 2018-03-09
• Study First Posted: 2018-03-12
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment group with Rivaroxaban	Rivaroxaban (Xarelto, BAY59-7939)	Patients treated with Rivaroxaban
Control group with VKAs	Vitamin K antagonists (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%).

Primary Outcome Measures

Name	Time	Method
Presence of stroke	12 months	Presence of stroke prior and subsequent to treatment
Active substance received	12 months	Rivaroxaban or VKAs (Acenocoumarol and Warfarin)
Time in therapeutic range (TTR) values in the last 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Frequency of the prescribed treatment (in hours)	12 months
Date of stroke	12 months
Duration of treatment (in days)	12 months
Type of stroke	12 months	Type of stroke acccording to patients group: unknown, haemorrhagic or ischaemic.
Dose of the prescribed treatment	12 months