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Oral Anticoagulant Discontinuation, Adherence Patterns, Hospitalizations and Costs in Non-Valvular Atrial Fibrillation (NVAF) Patients

Oral Anticoagulant Bleeding Rate and Discontinuation and Adherence Patterns in Non-Valvular Atrial Fibrillation (NVAF) Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02792335
Enrollment
28000
Registered
2016-06-07
Start date
2012-01-31
Completion date
2014-08-31
Last updated
2016-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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).

Interventions

DRUGapixaban
DRUGdabigatran
DRUGrivaroxaban
DRUGwarfarin

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Discontinuation rate of patients with prior warfarin useup to 31 months
Rate of major bleeding events of patients with prior warfarin useup to 31 months
Rate of hospitalization due to major bleeding events of patients with warfarin useup to 31 months
Discontinuation rate of patients who were naïve to oral anticoagulantup to 31 months
Rate of major bleeding events of patients who were naïve to oral anticoagulantup to 31 months
Rate of hospitalization due to major bleeding events of patients who were naïve to oral anticoagulantup to 31 months

Secondary

MeasureTime frame
All-Cause Healthcare per patient per month (PPPM) costup to 31 months
Rate of All-Cause Hospitalizationup to 31 months
AF-related Healthcare per patient per month (PPPM) costup to 31 months
Rate of Atrial Fibrillation(AF)-Related Hospitalizationup to 31 months
Rate of All-Cause Any Rehospitalizationup to 31 months
Rate of AF-Related Any Rehospitalizationup to 31 months
Rate of All-Cause Early Hospitalizationup to 31 months
Rate of AF-Related Early Hospitalizationup to 31 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026