Medical Need of OAC Reversal

Boehringer Ingelheim

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Rivaroxaban; Drug: Apixaban; Drug: dabigatran; Drug: warfarin; Drug: Edoxaban

Study type: Observational

Funder types: Industry

Identifiers

NCT03254147

1321-0022

Details and patient eligibility

About

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

Full 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.

Enrollment: 53,969 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

53,969 participants in 1 patient group

patients prescribed with Oral Anti-coagulants

Description:

warfarin and non-vitamin K dependent oral anti-coagulants

Treatment:

Drug: Apixaban

Drug: Rivaroxaban

Drug: dabigatran

Drug: Edoxaban

Drug: warfarin