check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

18231

ClinicalTrials.gov Identifier:

NCT03462446

EudraCT Number:

Not Available

EU CT Number:

Not Available
Analysis of the Potential savings of Rivaroxaban Events versus Vitamin K Antagonists events

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

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

  • -

Trial summary

Enrollment Goal
249
Trial Dates
June 2015 - May 2016
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
N/A

Where to participate

StatusInstitutionLocation
Completed
Granada, Spain

Primary Outcome

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

Secondary Outcome

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

Trial design

Estimate of costs associated with atrial fibrillation treatment with Rivaroxaban versus Vitamin K Antagonists
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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