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

May 12, 2022 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12354

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Minato-ku, Tokyo, Japan, 1080074
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients' medical charts with newly initiating warfarin or apixaban within the identification period fulfilling the study eligibility criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient initiating warfarin
Other: Non-Interventional
Non-Interventional
Patient initiating apixaban
Other: Non-Interventional
Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of major bleeding among oral anticoagulant (OAC) initiators
Time Frame: Maximum 3 years
Maximum 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 21, 2018

Primary Completion (ACTUAL)

December 25, 2020

Study Completion (ACTUAL)

December 25, 2020

Study Registration Dates

First Submitted

November 26, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (ACTUAL)

December 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-698

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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