Skip to main content
OpenTrials
Completed

NCT Number: NCT03254147

Medical Need of OAC Reversal

This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, Japan

About this study

This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF, the incidence rates of emergency surgery, major bleeding due to trauma, and major bleeding due to fracture, overall and stratified by age (<64, 65-74, >75). The secondary objective is to estimate the overall and age stratified incidence of cardiac tamponade and peri-cardiocentesis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

->18 year old non-valvular atrial fibrillation (NVAF) patients

  • Prescribed dabigatran, rivaroxaban, apixaban, edoxaban or warfarin
  • Patients with confirmed date of initiation of OACs
  • Patients with a minimum of 6 months of enrolment data prior to index date
  • Has an index date between 14th of March 2011 to 30 June, 2016

Exclusion criteria

  • Patients receiving two or more oral anti-coagulants at the same time at index date
  • Patients with prescriptions of index treatment in the 6 months prior to index date
  • Patients without enrolment period of at least six month in the database

Treatment and study plan

Warfarin

Drug

warfarin

dabigatran

Drug

Non-vitamin K dependent oral anti-coagulants (NOACs)

Other names: PRADAXA, PRAZAXA

Apixaban

Drug

Non-vitamin K dependent oral anti-coagulants (NOACs)

Edoxaban

Drug

Non-vitamin K dependent oral anti-coagulants (NOACs)

Rivaroxaban

Drug

Non-vitamin K dependent oral anti-coagulants (NOACs)

Primary outcomes

  1. The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.

    Time frame: One year

    The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.

Secondary outcomes

  1. The Number of Patients With Cardiac Tamponade and Pericardiocentesis.

    Time frame: One year

    The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Medical Need of Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Head Trauma, Fracture, and Emergency Surgery Using Large Scale Claims Database (Please Note That This Study Contains no Patients Treated With Idarucizumab Although the Study Number Begins With 1321; the Study Contains Only Patients Treated With OACs, Namely Warfarin, Dabigatran, Edoxaban, Apixaban, Rivaroxaban, Edoxaban)

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2017
Registry last updated
Mar 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.