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)
Overview
- Phase
- Not Applicable
- Intervention
- warfarin
- Conditions
- Atrial Fibrillation
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 53969
- Locations
- 1
- Primary Endpoint
- The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF
Detailed Description
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
patients prescribed with Oral Anti-coagulants
warfarin and non-vitamin K dependent oral anti-coagulants
Intervention: warfarin
patients prescribed with Oral Anti-coagulants
warfarin and non-vitamin K dependent oral anti-coagulants
Intervention: dabigatran
patients prescribed with Oral Anti-coagulants
warfarin and non-vitamin K dependent oral anti-coagulants
Intervention: Apixaban
patients prescribed with Oral Anti-coagulants
warfarin and non-vitamin K dependent oral anti-coagulants
Intervention: Edoxaban
patients prescribed with Oral Anti-coagulants
warfarin and non-vitamin K dependent oral anti-coagulants
Intervention: Rivaroxaban
Outcomes
Primary Outcomes
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
- The Number of Patients With Cardiac Tamponade and Pericardiocentesis.(One year)