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Completed

NCT Number: NCT03765242

Evaluation of Safety and Effectiveness on Oral Anticoagulants

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac 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

Minato-ku, Tokyo, 1080074, Japan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. Incidence of major bleeding among oral anticoagulant (OAC) initiators

    Time frame: Maximum 3 years

Secondary outcomes

  1. Incidence of thromboembolic events

    Time frame: Maximum 3 years

  2. Incidence of stoke/SE (secondary event) among OAC initiators

    Time frame: Maximum 3 years

  3. 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)

  4. Incidence of cardiovascular/all cause death among OAC initiators

    Time frame: Maximum 3 years

  5. Incidence of myocardial infarction among OAC initiators

    Time frame: Maximum 3 years

  6. Incidence of major adverse cardiac event among OAC initiators

    Time frame: Maximum 3 years

  7. 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)

  8. Incidence of myocardial infarction among OAC initiators stratified by CCr

    Time frame: Maximum 3 years

    CCr (< 50ml/min and > 50ml/min)

  9. Incidence of major adverse cardiac event among OAC initiators stratified by CCr

    Time frame: Maximum 3 years

    CCr (< 50ml/min and > 50ml/min)

  10. Distribution of clinical characteristics among OAC initiators

    Time frame: Maximum 3 years

    Clinical characteristics will be summarized using descriptive statistics

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: RCR-OAC

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2018
Registry last updated
May 13, 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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