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OpenTrials
Completed

NCT Number: NCT03462446

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Granada, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

As prescribed by treating physicians

Vitamin K antagonists (VKAs)

Drug

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

Primary outcomes

  1. Time in therapeutic range (TTR) values in the last 6 months

    Time frame: 6 months

  2. Presence of stroke

    Time frame: 12 months

    Presence of stroke prior and subsequent to treatment

  3. Active substance received

    Time frame: 12 months

    Rivaroxaban or VKAs (Acenocoumarol and Warfarin)

Secondary outcomes

  1. Date of stroke

    Time frame: 12 months

  2. Type of stroke

    Time frame: 12 months

    Type of stroke acccording to patients group: unknown, haemorrhagic or ischaemic.

  3. Duration of treatment (in days)

    Time frame: 12 months

  4. Dose of the prescribed treatment

    Time frame: 12 months

  5. Frequency of the prescribed treatment (in hours)

    Time frame: 12 months

Other outcomes

  1. Date of AF diagnosis

    Time frame: 12 months

  2. Comorbidities

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 12, 2018
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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