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OpenTrials
Completed

NCT Number: NCT03508271

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Ann Arbor, Michigan, 48104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. Incidence of stroke/systemic embolism (SE)

    Time frame: Approximately 195 weeks

  2. Incidence of major bleeding

    Time frame: Approximately 195 weeks

Secondary outcomes

  1. Incidence of miocardial infarction (MI)

    Time frame: Approximately 195 weeks

  2. Incidence of all cause mortality

    Time frame: Approximately 195 weeks

  3. Incidence of all cause hospitalization

    Time frame: Approximately 195 weeks

  4. Incidence of major adverse cardiac event

    Time frame: Approximately 195 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2018
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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