Evaluation of Safety and Effectiveness on Oral Anticoagulants

Atrial Fibrillation Clinical Trial

— RCR-OAC  

Official title:

Retrospective Medical Chart Review Study for Atrial Fibrillation Patents Treated With Oral Anticoagulant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765242
• Other study ID #: CV185-698
• Status: Completed
• Start date: September 21, 2018
• Est. completion date: December 25, 2020

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12354
• Est. completion date: December 25, 2020
• Est. primary completion date: December 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
Japan	Local Institution	Minato-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major bleeding among oral anticoagulant (OAC) initiators		Maximum 3 years
Secondary	Incidence of thromboembolic events		Maximum 3 years
Secondary	Incidence of stoke/SE (secondary event) among OAC initiators		Maximum 3 years
Secondary	Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr	CCr creatinine clearance (< 50ml/min and > 50ml/min)	Maximum 3 years
Secondary	Incidence of cardiovascular/all cause death among OAC initiators		Maximum 3 years
Secondary	Incidence of myocardial infarction among OAC initiators		Maximum 3 years
Secondary	Incidence of major adverse cardiac event among OAC initiators		Maximum 3 years
Secondary	Incidence of cardiovascular/all cause death among OAC initiators stratified by CCr (creatinine clearance rate)	CCr (< 50ml/min and > 50ml/min)	Maximum 3 years
Secondary	Incidence of myocardial infarction among OAC initiators stratified by CCr	CCr (< 50ml/min and > 50ml/min)	Maximum 3 years
Secondary	Incidence of major adverse cardiac event among OAC initiators stratified by CCr	CCr (< 50ml/min and > 50ml/min)	Maximum 3 years
Secondary	Distribution of clinical characteristics among OAC initiators	Clinical characteristics will be summarized using descriptive statistics	Maximum 3 years

External Links

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