Medical Need of OAC Reversal

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: warfarin
* Drug: dabigatran
* Drug: Apixaban
* Drug: Edoxaban
* Drug: Rivaroxaban


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients prescribed with Oral Anti-coagulants<br>warfarin and non-vitamin K dependent oral anti-coagulants | Drug: warfarin<br>* warfarin<br>Drug: dabigatran<br>* Non-vitamin K dependent oral anti-coagulants (NOACs)<br>* Other names: PRADAXA, PRAZAXA;Drug: Apixaban<br>* Non-vitamin K dependent oral anti-coagulants (NOACs)<br>Drug: Edoxaban<br>* Non-vitamin K dependent oral anti-coagulants (NOACs)<br>Drug: Rivaroxaban<br>* Non-vitamin K dependent oral anti-coagulants (NOACs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma. | 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. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients With Cardiac Tamponade and Pericardiocentesis. | 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. | One year |