Status:
COMPLETED
Evaluation of Safety and Effectiveness on Oral Anticoagulants
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Pfizer
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
20+ years
Brief Summary
This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 21 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 25 2020
Estimated Enrollment :
12354 Patients enrolled
Trial Details
Trial ID
NCT03765242
Start Date
September 21 2018
End Date
December 25 2020
Last Update
May 13 2022
Active Locations (1)
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1
Local Institution
Minato-ku, Tokyo, Japan, 1080074