Replication Of An Early Evaluation Of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin In The U.S

Completed

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

• Registration Number: NCT02769078
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The overall objective of this proposal is to execute a real-world database analysis to evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF) patients in the U.S.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-05
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-10
• Last Update Submitted: 2016-05-10
• Study First Posted: 2016-05-11
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14201

Inclusion Criteria

• Have a primary or secondary diagnosis of AF identified by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes from the Cerner Health Facts hospital database between January 1, 2012 and August 31, 2014
• Age 18 years or older as of initial hospitalization with AF diagnosis

Exclusion Criteria

• Have any primary or secondary diagnosis code or procedure code for valvular disease during the study period. This exclusion criterion is consistent with that used in other previous BMS Health Economics and Outcomes Research (HEOR) studies and is used to ensure that the study populations are NVAF patients
• Received multiple types of NOACs during the index hospitalization. Preliminary analysis showed that very few patients receive multiple types of NOACs during the same hospitalization. This exclusion criterion will allow to cleanly group patients into the different New oral anticoagulant (NOAC) usage groups

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who received warfarin	warfarin	Patients who received warfarin
Patients who received dabigatran	dabigatran	Patients who received dabigatran
Patients who received rivaroxaban	rivaroxaban	Patients who received rivaroxaban
Patients who received apixaban	apixaban	Patients who received apixaban

Primary Outcome Measures

Name	Time	Method
Proportion of NVAF patients with bleeding-related hospital readmissions from inpatient hospitalization records collected from the Cerner Health Facts hospital database	January 1, 2012 to August 31, 2014	Proportion of NVAF patients with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban, or warfarin in the inpatient setting.

Secondary Outcome Measures

Name	Time	Method
Cost associated with bleeding-related hospital readmissions from inpatient hospitalization records collected from the Cerner Health Facts hospital database	January 1, 2012 to August 31, 2014	Cost associated with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban, or warfarin in the inpatient setting
Proportion of NVAF patients with all cause hospital readmissions and the associated costs from inpatient hospitalization records collected from the Cerner Health Facts hospital database	January 1, 2012 to August 31, 2014	Proportion of NVAF patients with all cause hospital readmissions and the associated costs that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban, or warfarin in the inpatient setting.