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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: apixaban; Drug: dabigatran; Drug: rivaroxaban; Drug: warfarin

• Registration Number: NCT02792335
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-06
• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-06
• Last Update Submitted: 2016-06-06
• Study First Posted: 2016-06-07
• Last Update Posted: 2016-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients naive to oral anticoagulant treatment	rivaroxaban	NVAF patients naïve to oral anticoagulant treatment (Naïve)
patients naive to oral anticoagulant treatment	apixaban	NVAF patients naïve to oral anticoagulant treatment (Naïve)
patients with prior warfarin therapy	apixaban	NVAF patients with prior warfarin therapy (Warfarin treated)
patients naive to oral anticoagulant treatment	dabigatran	NVAF patients naïve to oral anticoagulant treatment (Naïve)
patients with prior warfarin therapy	dabigatran	NVAF patients with prior warfarin therapy (Warfarin treated)
patients with prior warfarin therapy	rivaroxaban	NVAF patients with prior warfarin therapy (Warfarin treated)
patients with prior warfarin therapy	warfarin	NVAF patients with prior warfarin therapy (Warfarin treated)

Primary Outcome Measures

Name	Time	Method
Rate of major bleeding events of patients with prior 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
Discontinuation rate 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
Rate of hospitalization due to major bleeding events of patients who were naïve to oral anticoagulant	up to 31 months

Secondary Outcome Measures

Name	Time	Method
Rate of AF-Related Early Hospitalization	up to 31 months
Rate of AF-Related Any Rehospitalization	up to 31 months
Rate of All-Cause 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
Rate of All-Cause Any Rehospitalization	up to 31 months
Rate of All-Cause Hospitalization	up to 31 months
Rate of Atrial Fibrillation(AF)-Related Hospitalization	up to 31 months