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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754154
• Other study ID #: CV185-433
• Status: Completed
• Start date: December 31, 2014
• Est. completion date: December 26, 2018

Study information

• Verified date: April 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321182
• Est. completion date: December 26, 2018
• Est. primary completion date: December 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Warfarin

• Apixaban

• Dabigatran

• Rivaroxaban

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to "First Major" Bleeding event		Up to 25 months
Secondary	Time to "First Any" Bleeding event		Up to 25 months
Secondary	Major Bleeding-Related Healthcare Utilization	(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 )	Up to 25 months
Secondary	Any Bleeding-Related Healthcare Utilization	(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 )	Up to 25 months
Secondary	Major Bleeding-Related direct medical cost	(Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 major bleeding event)	Up to 25 months
Secondary	Any Bleeding-Related direct medical cost	(Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 bleeding event)	Up to 25 months

External Links

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