Medical Need of OAC Reversal

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: warfarin; Drug: dabigatran; Drug: Apixaban; Drug: Edoxaban; Drug: Rivaroxaban

• Registration Number: NCT03254147
• Lead Sponsor: Boehringer Ingelheim

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.

Study Timeline

• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-18
• Study Start: 2017-10-15
• Primary Completion: 2017-10-30
• Study Completion: 2017-11-10
• Status Verified: 2018-10
• Results First Submitted: 2018-10-31
• Results First Submitted QC: 2018-10-31
• Last Update Submitted: 2018-10-31
• Results First Posted: 2019-03-04
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53969

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients prescribed with Oral Anti-coagulants	dabigatran	warfarin and non-vitamin K dependent oral anti-coagulants
patients prescribed with Oral Anti-coagulants	warfarin	warfarin and non-vitamin K dependent oral anti-coagulants
patients prescribed with Oral Anti-coagulants	Edoxaban	warfarin and non-vitamin K dependent oral anti-coagulants
patients prescribed with Oral Anti-coagulants	Apixaban	warfarin and non-vitamin K dependent oral anti-coagulants
patients prescribed with Oral Anti-coagulants	Rivaroxaban	warfarin and non-vitamin K dependent oral anti-coagulants

Primary Outcome Measures

Name	Time	Method
The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.	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 Outcome Measures

Name	Time	Method
The Number of Patients With Cardiac Tamponade and Pericardiocentesis.	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.

Trial Locations

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd.; 🇯🇵 Tokyo, Japan