check_circleStudy Completed

Atrial fibrillation

Bayer Identifier:

22154

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
REal-World Treatment Outcomes of Oral Anticoagulants among Patients with Atrial Fibrillation - RETAF

Trial purpose

The study aims to understand the current landscape of OAC (Oral anticoagulants) treatment and non-treatment in patients diagnosed with AF (Atrial fibrillation); and examine the adherence, persistence, and discontinuation rates and outcomes among those treated with apixaban.

Key Participants Requirements

Sex

All

Age

45 - N/A
  • -Patients with age ≥45 years as of index date.
    -Patients with ≥12 months pre-index (baseline) continuous medical and pharmacy enrollment.
    -Patient with > 3 months (92 days) post-index continuous medical and pharmacy enrollment.
  • for cohort 1:
    -Patients with diagnosis of AF or or with claims of OAC(s) in the 12 months pre-index
    -Patients with one of the diagnoses associated with transient AF (i.e., pericarditis, hyperthyroidism or thyrotoxicity) in the 12 months pre-index.
    -Patients with cardiac surgery in the 12 months pre-index including the date of the index AF diagnosis.
    -Patients with diagnoses of venous thromboembolism (DVT and PE), hip or knee replacement) within 6 months (183 days) pre-index.

Trial summary

Enrollment Goal
300
Trial Dates
June 2022 - November 2023
Phase
N/A
Could I Receive a placebo
No
Products
Eliquis (Apixaban)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
BayerWhippany, 07981, US

Primary Outcome

  • Descriptive analysis of demographic
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2016 to 31-OCT-2021
  • Desacriptive analysis of clinical characteristics
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2016 to 31-Oct-2021

Secondary Outcome

  • Length of post-index following up
    Average length of follow up at post-index period in months
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2016 to 31-Oct-2021
  • Patients censored due to death within 30 days from last apixaban supply.
    Total number of patients who are censored by death within 30 days from the last apixaban supply date during the first apixaban regimen
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2016 to 31-Oct-2021
  • Length of post-index following up for patients who are lost to follow up due to death
    Average length of follow up at post-index in months for those who have death date.
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2016 to 31-Oct-2021
  • Adherence to apixaban at post-index period (measured by PDC)
    PDC: Proportion of days covered for apixaban from initiation of therapy to apixaban discontinuation or end of follow up
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2016 to 31-Oct-2021
  • Persistence to index apixaban (using 30-day gap) over post-index follow up
    Persistence is measured by the duration of time from initiation to discontinuation of therapy.
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2016 to 31-Oct-2021
  • Persistence at 3/6/9/12/24 months post-index
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2016 to 31-Oct-2021
  • Apixaban discontinuation without re-initiating or switching (using 30-days gap)
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2016 to 31-OCT-2021
  • Apixaban discontinuation with re-initiation.
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2016 to 31-OCT-2021
  • Switching from apixaban to another OAC
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2016 to 31-OCT-2021
  • Time to first switch from last apixaban prescription
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2016 to 31-OCT-2021
  • Augmentation with an antiplatelet medication
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2016 to 31-OCT-2021

Trial design

REal-World Treatment Outcomes of Oral Anticoagulants among Patients with Atrial Fibrillation
Trial Type
Observational
Intervention Type
Other
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A