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

May 10, 2016 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Patients who received any of the NOACs, dabigatran, rivaroxaban, apixaban, or warfarin during any time of the hospitalization (from admission to discharge)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who received dabigatran
Drug: dabigatran
Patients who received rivaroxaban
Drug: rivaroxaban
Patients who received apixaban
Drug: apixaban
Patients who received warfarin
Drug: warfarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of NVAF patients with bleeding-related hospital readmissions from inpatient hospitalization records collected from the Cerner Health Facts hospital database
Time Frame: 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.
January 1, 2012 to August 31, 2014

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost associated with bleeding-related hospital readmissions from inpatient hospitalization records collected from the Cerner Health Facts hospital database
Time Frame: 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
January 1, 2012 to August 31, 2014
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
Time Frame: 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.
January 1, 2012 to August 31, 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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