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Completed

NCT Number: NCT05027061

A Study of Participants With Non-Valvular Atrial Fibrillation (NVAF) Treated or Untreated With Oral Anticoagulant in the National Cerebral and Cardiovascular Center (NCVC) in Japan

The purpose of this observational study is to understand real-world oral anticoagulants (OAC) (warfarin, apixaban, dabigatran, edoxaban and rivaroxaban) usage for non-valvular atrial fibrillation (NVAF) patients.

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Key information

Conditions

Non-valvular Atrial Fibrillation (NVAF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Tokyo, 1070052, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants received medical treatment for NVAF between 10-Jan-2012 and 31-Aug-2020.

Exclusion criteria

  • Had no data of serum creatinine in the participant's medical records
  • Had no data of body weight in the participant's medical records
  • Were given oral anticoagulant (OAC) for treatment of diseases other than atrial fibrillation (AF)

Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

Primary outcomes

  1. Specialization of the treating physician

    Time frame: At Baseline

  2. Distribution of socio-demographic characteristics of NVAF participants: Age group

    Time frame: At Baseline

  3. Distribution of socio-demographic characteristics of NVAF participants: Gender

    Time frame: At Baseline

  4. Distribution of socio-demographic characteristics of NVAF participants: Body weight

    Time frame: At Baseline

  5. Distribution of socio-demographic characteristics of NVAF participants: Height

    Time frame: At Baseline

  6. Distribution of socio-demographic characteristics of NVAF participants: Body mass index (BMI)

    Time frame: At Baseline

  7. Distribution of outcomes of NVAF participants: Drinking information

    Time frame: At Baseline

  8. Distribution of outcomes of NVAF participants: Smoking information

    Time frame: At Baseline

  9. Distribution of outcomes of NVAF participants: Internal medical device information

    Time frame: At Baseline

  10. Distribution of outcomes of NVAF participants: Degree of life freedom

    Time frame: At Baseline

  11. Distribution of outcomes of NVAF participants: Hospitalization/outpatient status

    Time frame: At Baseline

  12. Distribution of outcomes of NVAF participants: Systolic and diastolic blood pressure

    Time frame: At Baseline

  13. Distribution of outcomes of NVAF participants: Pulse rate

    Time frame: At Baseline

  14. Distribution of clinical characteristics of NVAF participants: Risk factors for stroke

    Time frame: At Baseline

  15. Distribution of clinical characteristics of NVAF participants: Risk factors for bleeding

    Time frame: At Baseline

  16. Distribution of clinical characteristics of NVAF participants: Comorbidities

    Time frame: At Baseline

  17. Distribution of outcomes of NVAF participants: OAC prescription and administration status

    Time frame: At Baseline

  18. Distribution of medication prescribed during baseline: angiotensin-converting enzyme inhibitor (ACE)

    Time frame: At Baseline

  19. Distribution of medication prescribed during baseline: angiotensin-receptor blocker (ARB)

    Time frame: At Baseline

  20. Distribution of medication prescribed during baseline: calcium antagonist

    Time frame: At Baseline

  21. Distribution of medication prescribed during baseline: Antiarrhythmic drug

    Time frame: At Baseline

  22. Distribution of medication prescribed during baseline: Statin

    Time frame: At Baseline

  23. Distribution of medication prescribed during baseline: proton pump inhibitor (PPI)

    Time frame: At Baseline

  24. Distribution of medication prescribed during baseline: H2-receptor antagonist

    Time frame: At Baseline

  25. Distribution of medication prescribed during baseline: aspirin

    Time frame: At Baseline

  26. Distribution of medication prescribed during baseline: P2Y12 inhibitor

    Time frame: At Baseline

  27. Distribution of medication prescribed during baseline: Other antiplatelet drugs

    Time frame: At Baseline

  28. Distribution of medication prescribed during baseline: Other anticoagulants

    Time frame: At Baseline

  29. Distribution of medication prescribed during baseline: P-glycoprotein inhibitor

    Time frame: At Baseline

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Retrospective Medical Chart Review Study for Non-valvular Atrial Fibrillation Patients Treated or Untreated With Oral Anticoagulant in the National Cerebral and Cardiovascular Center (NCVC) in Japan

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 30, 2021
Registry last updated
Mar 17, 2022

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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