Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03462446
Recruitment Status : Completed
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Vitamin K antagonists (VKAs)

Layout table for study information
Study Type : Observational
Actual Enrollment : 249 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Estimate of Costs Associated With Atrial Fibrillation Treatment With Rivaroxaban Versus Vitamin K Antagonists
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : May 1, 2016
Actual Study Completion Date : May 1, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Treatment group with Rivaroxaban
Patients treated with Rivaroxaban
Drug: Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by treating physicians

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%).
Drug: Vitamin K antagonists (VKAs)
As prescribed by treating physicians. VKAs are Acenocoumarol and Warfarin.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Date of AF diagnosis [ Time Frame: 12 months ]
  2. Comorbidities [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Selected population will include records registered in electronic databases of patients diagnosed with nonvalvular AF, receiving treatment with VKAs or rivaroxaban for one year.
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462446


Locations
Layout table for location information
Spain
Granada, Spain
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer

Additional Information:
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03462446     History of Changes
Other Study ID Numbers: 18231
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Atrial fibrillation
VKA
Stroke
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamins
Vitamin K
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants