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

NCT02769078 | Completed

• 1 other identifier: CV185-425
• Study Type: observational
• Target: 14,201
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Keywords

Anticoagulation

Outcome Measures

Primary Outcomes (1)

• Proportion of NVAF patients with bleeding-related hospital readmissions from inpatient hospitalization records collected from the Cerner Health Facts hospital database

  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 Outcomes (2)

• 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

• 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

Study Arms (4)

Patients who received dabigatran

Patients who received dabigatran

Drug: dabigatran

Patients who received rivaroxaban

Patients who received rivaroxaban

Drug: rivaroxaban

Patients who received apixaban

Patients who received apixaban

Drug: apixaban

Patients who received warfarin

Patients who received warfarin

Drug: warfarin

Interventions

dabigatran DRUG

Patients who received dabigatran

rivaroxaban DRUG

Patients who received rivaroxaban

apixaban DRUG

Patients who received apixaban

warfarin DRUG

Patients who received warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• Investigator Inquiry form
• BMS Clinical Trial Education Resource

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran; Rivaroxaban; apixaban; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 11, 2016
• Study Start: November 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 11, 2016

Record last verified: 2016-05