Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02754154
• Collaborator: (none)
• Enrollment: 321,182
• Actual Duration (Months): 47.8

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Warfarin; Drug: Apixaban; Drug: Dabigatran; Drug: Rivaroxaban

Study Design

• Study Type: Observational
• Actual Enrollment: 321182 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants
• Actual Study Start Date: Dec 31, 2014
• Actual Primary Completion Date: Dec 26, 2018
• Actual Study Completion Date: Dec 26, 2018

Arms and Interventions

Arm	Intervention/Treatment
Patients using Warfarin Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Warfarin	Drug: Warfarin
Patients using Apixaban Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Apixaban	Drug: Apixaban
Patients using Dabigatran Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Dabigatran	Drug: Dabigatran
Patients using Rivaroxaban Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Rivaroxaban	Drug: Rivaroxaban

Outcome Measures

Primary Outcome Measures

1. Time to "First Major" Bleeding event [Up to 25 months]

Secondary Outcome Measures

1. Time to "First Any" Bleeding event [Up to 25 months]

2. Major Bleeding-Related Healthcare Utilization [Up to 25 months]

   (Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 major bleeding event )

3. Any Bleeding-Related Healthcare Utilization [Up to 25 months]

   (Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 bleeding event )

4. Major Bleeding-Related direct medical cost [Up to 25 months]

   (Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 major bleeding event)

5. Any Bleeding-Related direct medical cost [Up to 25 months]

   (Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 bleeding event)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients ≥18 years old as of the index date

• At least 1 diagnosis of atrial fibrillation in the 12 months prior to or on index date, identified by any medical claim

• At least one year of baseline period and continuous enrollment for at least 12 months prior to index date Individuals with NVAF who were using oral anticoagulants (i.e., warfarin, dabigatran, rivaroxaban and apixaban) within the study period beginning Jan 1, 2012 through December 31, 2013 or last date of the last data cut available at the time of execution of the study

Exclusion Criteria:

• Patients with evidence of valvular heart disease, thyrotoxicosis, pericarditis, mitral stenosis, Venous thromboembolism(VTE), heart surgery, and endocarditis during the baseline period any time prior to or on index date

• Patients with any evidence of pregnancy at any time during the baseline will be excluded

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02754154
• Other Study ID Numbers: CV185-433
• First Posted: Apr 28, 2016
• Last Update Posted: May 9, 2022
• Last Verified: Apr 1, 2022

• Additional relevant MeSH terms: Atrial Fibrillation; Warfarin; Rivaroxaban; Dabigatran; Apixaban

Study Results

No Results Posted as of May 9, 2022