Effectiveness of Oral Anticoagulants in Elderly Patients With Non-Valvular Atrial Fibrillation and Heart Failure

January 2, 2019 updated by: Bristol-Myers Squibb

Real-World Comparative Effectiveness Research Among Elderly Non-valvular Atrial Fibrillation (NVAF) Patients With Heart Failure (HF) Using Oral Anticoagulants

Observational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation and Heart Failure who are beginning oral blood thinners

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60000

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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • 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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Elderly individuals diagnosed with NVAF (non-valvular atrial fibrillation) and HF (heart failure) who are new initiators of DOAC's (direct oral anticoagulants)

Description

Inclusion Criteria:

  • Were age greater than or equal to 65 years as of the index date
  • Had greater than or equal to 1 diagnosis of AF prior to or on the index date
  • Had greater than or equal to 1 diagnosis claim of HF during the 12 months prior to or on the index date
  • Had 1 or more pharmacy claim for oral blood thinners

Exclusion Criteria:

  • Claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date
  • Pharmacy claim for warfarin, apixaban, dabigatran, edoxaban or rivaroxaban during the 12-month baseline period
  • Greater than 1 oral anticoagulants prescription claim on the index date and/or with a follow-up less than 1 day
  • Had medical claim indicating VTE in the 12 months prior to 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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elderly individuals with NVAF and HF who are taking OAC's
Other: Non-Interventional
Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of stroke/systemic embolism (SE)
Time Frame: Approximately 195 weeks
Approximately 195 weeks
Incidence of major bleeding
Time Frame: Approximately 195 weeks
Approximately 195 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of miocardial infarction (MI)
Time Frame: Approximately 195 weeks
Approximately 195 weeks
Incidence of all cause mortality
Time Frame: Approximately 195 weeks
Approximately 195 weeks
Incidence of all cause hospitalization
Time Frame: Approximately 195 weeks
Approximately 195 weeks
Incidence of major adverse cardiac event
Time Frame: Approximately 195 weeks
Approximately 195 weeks

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

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)

November 30, 2017

Primary Completion (Actual)

November 8, 2018

Study Completion (Actual)

November 8, 2018

Study Registration Dates

First Submitted

April 16, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (Actual)

April 25, 2018

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-681

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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