Clinical trial NCT02492828: Adherence of Apixaban and Warfarin in Patients With Arterial Fibrillation in Real-world Setting in Sweden
Official title: Adherence of Apixaban and Warfarin in Patients With Atrial Fibrillation in Real-world Setting in Sweden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-07-09
Enrollment: 41000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include all patients with filled prescriptions for apixaban or warfarin between May 29, 2013 and Dec 31, 2014 that are identified with a hospital diagnosis of non-valvular atrial fibrillation (NVAF)

Brief summary: This will be a retrospective cohort study using national register linkage data (including prescription, inpatient, mortality, and socioeconomic data). The study period will be from May 29, 2013 to June 30, 2015. Patients will be followed from the start of treatment (index date) until their death, exiting the database, or until the end of the study period (June 30, 2015).


Eligibility criteria: Inclusion Criteria:

* For the AF cohort

  * Patients that have ≥1 AF diagnosis registered in the patient register
* Apixaban subcohort 1

  * Patients eligible for the AF cohort
  * Patients that had a first prescription for apixaban during the identification period without previous prescriptions for NOACs or warfarin during the preceding 12 months
* Warfarin subcohort 1

  * Patients eligible for the AF cohort
  * Patients that had a first prescription for warfarin during the identification period without previous prescriptions for NOACs or warfarin during the preceding 12 months
* Apixaban subcohort 2

  * Patients eligible for the AF cohort
  * Patients that had a first prescription for apixaban during

Exclusion Criteria:

* For the AF cohort:

  * Patients with valvular AF will be excluded (see definition Appendix 1)
* Warfarin subcohort 1:

  * Patients will be excluded from this sub-cohort if they had at least one prescription for warfarin or NOACs during the 12-month period preceding the first prescription for warfarin during the identification period, ie, the index date

Primary outcomes:
measure: Compare adherence among Atrial Fibrillation (AF) patients initiating treatment with apixaban (without previous warfarin or novel anticoagulant (NOAC) use) compared with those initiating treatment with warfarin (without previous warfarin or NOAC use)
timeFrame: approximately 6 to 12 months
measure: Compare persistence among AF patients initiating treatment with apixaban (without previous warfarin or NOAC use) compared with those initiating treatment with warfarin (without previous warfarin or NOAC use)
timeFrame: approximately 6 to 12 months
Secondary outcomes:
measure: Describe and compare patient characteristics (demographics) among AF patients through questionnaire
timeFrame: approximately 6 to 12 months
measure: Describe and compare patient characteristics (clinical) among AF patients through questionnaire
timeFrame: approximately 6 to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: