Medical Need of OAC Reversal

Atrial Fibrillation Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254147
• Other study ID #: 1321-0022
• Status: Completed
• Start date: October 15, 2017
• Est. completion date: November 10, 2017

Study information

• Verified date: October 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53969
• Est. completion date: November 10, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• warfarin
warfarin
• dabigatran
Non-vitamin K dependent oral anti-coagulants (NOACs)
• Apixaban
Non-vitamin K dependent oral anti-coagulants (NOACs)
• Edoxaban
Non-vitamin K dependent oral anti-coagulants (NOACs)
• Rivaroxaban
Non-vitamin K dependent oral anti-coagulants (NOACs)

Locations

Country	Name	City	State
Japan	Nippon Boehringer Ingelheim Co., Ltd.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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