Medical Need of OAC Reversal

Boehringer Ingelheim53,969 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

53,969

Conditions

Atrial Fibrillation

Interventions

warfarinDRUG

warfarin

dabigatranDRUG

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

ApixabanDRUG

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

Edoxaban

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, Japan

Outcomes

Primary Outcomes

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.

Time frame: One year

Secondary Outcomes

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.

Time frame: One year

Data from ClinicalTrials.gov

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