Evaluation of Safety and Effectiveness on Oral Anticoagulants

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Non-Interventional

• Registration Number: NCT03765242
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-09-21
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Primary Completion: 2020-12-25
• Study Completion: 2020-12-25
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12354

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient initiating warfarin	Non-Interventional	-
Patient initiating apixaban	Non-Interventional	-

Primary Outcome Measures

Name	Time	Method
Incidence of major bleeding among oral anticoagulant (OAC) initiators	Maximum 3 years

Secondary Outcome Measures

Name	Time	Method
Incidence of stoke/SE (secondary event) among OAC initiators	Maximum 3 years
Incidence of major adverse cardiac event among OAC initiators	Maximum 3 years
Incidence of major adverse cardiac event among OAC initiators stratified by CCr	Maximum 3 years	CCr (\< 50ml/min and \> 50ml/min)
Incidence of cardiovascular/all cause death among OAC initiators	Maximum 3 years
Incidence of myocardial infarction among OAC initiators	Maximum 3 years
Incidence of myocardial infarction among OAC initiators stratified by CCr	Maximum 3 years	CCr (\< 50ml/min and \> 50ml/min)
Distribution of clinical characteristics among OAC initiators	Maximum 3 years	Clinical characteristics will be summarized using descriptive statistics
Incidence of thromboembolic events	Maximum 3 years
Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr	Maximum 3 years	CCr creatinine clearance (\< 50ml/min and \> 50ml/min)
Incidence of cardiovascular/all cause death among OAC initiators stratified by CCr (creatinine clearance rate)	Maximum 3 years	CCr (\< 50ml/min and \> 50ml/min)

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Minato-ku, Tokyo, Japan