Clinical trial NCT02792335: Oral Anticoagulant Discontinuation, Adherence Patterns, Hospitalizations and Costs in Non-Valvular Atrial Fibrillation (NVAF) Patients
Official title: Oral Anticoagulant Bleeding Rate and Discontinuation and Adherence Patterns in Non-Valvular Atrial Fibrillation (NVAF) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-06-07
Enrollment: 28000
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 initial study population will include Non-valvular atrial fibrillation (NVAF) patients who initiated warfarin or Novel oral anticoagulants (NOACs) between January 01, 2012 and August 31, 2014. The date of the first NOAC prescription claim during the enrollment period will serve as the index date. The patients who have at least 1 year of baseline data available will be included in the study.

Brief summary: To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF) patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).


Eligibility criteria: Inclusion Criteria:

* Individuals with NVAF who were on warfarin and have switched to the NOACs (dabigatran, rivaroxaban and apixaban) within the study period January 01, 2013 through March 31, 2014
* Individuals ≥18 years old on the index date
* At least 1 year of baseline period with history of continuous warfarin use in the baseline period for at least 3 months immediately before the index date
* At least 1 diagnosis of AF in the 12 months prior to index date
* Continuous eligibility with medical and pharmacy benefits for at least 12 months before the index date through 1 month after the index date

Exclusion Criteria:

* Individuals with a diagnosis of valvular heart disease or cardiac surgery during the 12 months prior to index date

Primary outcomes:
measure: Discontinuation rate of patients with prior warfarin use
timeFrame: up to 31 months
measure: Rate of major bleeding events of patients with prior warfarin use
timeFrame: up to 31 months
measure: Rate of hospitalization due to major bleeding events of patients with warfarin use
timeFrame: up to 31 months
measure: Discontinuation rate of patients who were naïve to oral anticoagulant
timeFrame: up to 31 months
measure: Rate of major bleeding events of patients who were naïve to oral anticoagulant
timeFrame: up to 31 months
measure: Rate of hospitalization due to major bleeding events of patients who were naïve to oral anticoagulant
timeFrame: up to 31 months
Secondary outcomes:
measure: Rate of All-Cause Hospitalization
timeFrame: up to 31 months
measure: Rate of Atrial Fibrillation(AF)-Related Hospitalization
timeFrame: up to 31 months
measure: Rate of All-Cause Any Rehospitalization
timeFrame: up to 31 months
measure: Rate of AF-Related Any Rehospitalization
timeFrame: up to 31 months
measure: Rate of All-Cause Early Hospitalization
timeFrame: up to 31 months
measure: Rate of AF-Related Early Hospitalization
timeFrame: up to 31 months
measure: All-Cause Healthcare per patient per month (PPPM) cost
timeFrame: up to 31 months
measure: AF-related Healthcare per patient per month (PPPM) cost
timeFrame: up to 31 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: