check_circleStudy Completed

Non-valvular atrial fibrillation

Bayer Identifier:

20999

ClinicalTrials.gov Identifier:

NCT04174859

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study aims to collect information in routine clinical practice in Italy about the number of patients suffering from irregularly heart beats which are not caused by a heart valve problem (non-valvular atrial fibrillation, NVAF) who stopped or changed rivaroxaban treatment

Trial purpose

While it is well known that stopping or changing medication with blood thinners in patients who suffer from non-valvular atrial fibrillation (NVAF) increases the risk of ischemic stroke (a condition which occurs when a vessel supplying blood to the brain is obstructed), bleeding or thromboembolism (a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel), limited data are available on the number of NVAF patients and the reasons why NVAF patients in Italy stop or change their treatment with blood thinners to prevent stroke or thromboembolism.
By following the NVAF patients in routine clinical practice in Italy who are treated with rivaroxaban to prevent stroke or systemic embolism researchers want to find out how many NVAF patients and for what reasons NVAF patients stopped or changed rivaroxaban treatment. Study data will be collected through patients' routine visits at their treating doctor over a period of 24 months for each patient.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Age >= 18
    - Patient with a diagnosis of NVAF
    - New user to rivaroxaban, naïve or non naïve to treatment with oral anticoagulant
    - Patient for whom the decision to initiate treatment with rivaroxaban was made as per physician's routine treatment practice for prevention of stroke and non-central nervous system (CNS) systemic embolism
    - Signed an informed consent
  • - Patient with heart valve replacement
    - Patient is participating in an investigational program with interventions outside of routine clinical practice

Trial summary

Enrollment Goal
812
Trial Dates
December 2019 - December 2022
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Italy

Primary Outcome

  • Date of start of rivaroxaban treatment
    date_rangeTime Frame:
    24 months
  • Date of stop of rivaroxaban treatment
    date_rangeTime Frame:
    24 months
  • Number of patients who discontinue (i.e: number of discontinuation) from study initiation to end of observation/follow up.
    date_rangeTime Frame:
    24 months

Secondary Outcome

  • Reasons for discontinuation of rivaroxaban therapy
    - therapy discontinuation due to adverse event (AE) - therapy discontinuation for non AE related reason - physician decision - patient lost to follow up, no remote contact - patient decision (not related to AE) - patient is in stable sinus rhythm - patient decided to terminate study participation but agreed to further use of data collected so far. - patient decided to terminate study participation and refused further use of collected data. - Patient died - Treatment switch
    date_rangeTime Frame:
    24 months
  • Reason for dose change of rivaroxaban therapy
    - Change in Creatinine Clearance (CrCL) - Insufficient therapeutic effect - Adverse event
    date_rangeTime Frame:
    24 months
  • Reason for switch to other therapy
    - Ischemic event - Bleeding and site of bleeding - Adverse drug reaction - Drug interaction with other therapies - New treatment after switch
    date_rangeTime Frame:
    24 months
  • Treatment adherence: Self-reported medication adherence measured by the MMAS-8 (Morinsky Scale score)
    date_rangeTime Frame:
    24 months

Trial design

Rivaroxaban treatment discontinuation rates in routine clinical practice in Italy in patients with non-valvular atrial fibrillation
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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