Evaluation of Hospital Readmissions Among Hospitalized Non-valvular Atrial Fibrillation (NVAF) Patients in the US

NCT ID: NCT02674594

Last Updated: 2016-04-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2014-11-30

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

Primary objective: To determine the proportions of NVAF patients with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with the new oral anticoagulants (NOACs), dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting

Secondary objectives:

• To determine the 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
• To determine the proportions 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.

Conditions

Nonvalvular Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patient treated with Dabigatran

No interventions assigned to this group

Patient treated with Rivaroxaban

No interventions assigned to this group

Patient treated with Apixaban

No interventions assigned to this group

Patient treated with Warfarin

No interventions assigned to this group

Eligibility Criteria

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 Premier Hospital database between January 1, 2012 and December 31, 2013
• 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 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 new oral anticoagulants (NOACs) during the same hospitalization. This exclusion criterion will allow to cleanly group patients into the different NOAC usage groups

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CV185-405

Identifier Type: -

Identifier Source: org_study_id