Evaluation of Safety and Effectiveness on Oral Anticoagulants (RCR-OAC)

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Other: Non-Interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03765242

CV185-698

Details and patient eligibility

About

This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment

Enrollment: 12,354 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals greater than or equal to 20 years old as of the index date
• At least 1 diagnosis of NVAF prior to or on index date, identified by any medical records
• Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-2016. The first warfarin or apixaban prescription date during the identification period will be designated as the index date

Exclusion criteria

• Patient's medical records indicating pregnancy during the follow-up period
• Patient's medical records indicating taking warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 6-months prior to the index date
• Had > 1 OAC prescription in the patient's medical records on the index date

Other protocol defined inclusion/exclusion criteria could apply

Trial design

12,354 participants in 2 patient groups

Patient initiating warfarin

Treatment:

Other: Non-Interventional

Patient initiating apixaban

Treatment:

Other: Non-Interventional