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

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).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: warfarin; Drug: apixaban; Drug: rivaroxaban; Drug: dabigatran

• Study Type: Observational
• Enrollment (Actual): 28000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients naive to oral anticoagulant treatment; NVAF patients naïve to oral anticoagulant treatment (Naïve)	Drug: apixaban; Drug: rivaroxaban; Drug: dabigatran
patients with prior warfarin therapy; NVAF patients with prior warfarin therapy (Warfarin treated)	Drug: warfarin; Drug: apixaban; Drug: rivaroxaban; Drug: dabigatran

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Discontinuation rate of patients with prior warfarin use	up to 31 months
Rate of major bleeding events of patients with prior warfarin use	up to 31 months
Rate of hospitalization due to major bleeding events of patients with warfarin use	up to 31 months
Discontinuation rate of patients who were naïve to oral anticoagulant	up to 31 months
Rate of major bleeding events of patients who were naïve to oral anticoagulant	up to 31 months
Rate of hospitalization due to major bleeding events of patients who were naïve to oral anticoagulant	up to 31 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of All-Cause Hospitalization	up to 31 months
Rate of Atrial Fibrillation(AF)-Related Hospitalization	up to 31 months
Rate of All-Cause Any Rehospitalization	up to 31 months
Rate of AF-Related Any Rehospitalization	up to 31 months
Rate of All-Cause Early Hospitalization	up to 31 months
Rate of AF-Related Early Hospitalization	up to 31 months
All-Cause Healthcare per patient per month (PPPM) cost	up to 31 months
AF-related Healthcare per patient per month (PPPM) cost	up to 31 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 7, 2016

Study Record Updates

• Last Update Posted (Estimate): June 7, 2016
• Last Update Submitted That Met QC Criteria: June 6, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Dabigatran; Apixaban; Warfarin
• Other Study ID Numbers: CV185-412