Treatment Patterns and Bleeding Risk of Anticoagulants in Patients With Venous Thromboembolism in Korea

Pfizer

Status: Completed

Conditions: Venous Thromboembolism

Treatments: Drug: Warfarin; Drug: Dabigatran; Drug: Rivaroxaban; Drug: Parenteral anticoagulant; Drug: Apixaban; Drug: Edoxaban

Study type: Observational

Funder types: Industry

Identifiers

NCT05022563

VTE HIRA Study (Other Identifier)

X9001305

Details and patient eligibility

About

This study is a retrospective, observational, nationwide population-based cohort study utilizing the South Korea's Health Insurance and Review Assessment Service (HIRA) database. The aims of this study are to describe the sociodemographic and clinical characteristics of patients with venous thromboembolism according to their anticoagulant treatment (parenteral anticoagulants, warfarin, or non-vitamin K antagonist oral anticoagulants), to describe the treatment patterns related to anticoagulants, and to examine the risk of major bleeding according to the specific type of oral anticoagulants. The study will be conducted in two phases: Phase I for descriptive study and Phase II for comparative study.

Enrollment: 55,759 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Incident VTE diagnosis in an inpatient or outpatient setting between 1 Mar 2013 and 30 Jun 2019
2. Received anticoagulation therapy (all medication codes for anticoagulants approved for VTE in Korea; UFH, LMWH, warfarin, and NOACs) within 30 days of their VTE diagnosis (the index date will be defined as the date of treatment initiation with anticoagulants)
3. Aged ≥18 years at index date

Exclusion criteria

1. Had a record of VTE diagnosis within the 12-month period prior to the index VTE encounter.
2. Diagnosed with atrial fibrillation/flutter, mechanical heart valve replacement or mitral stenosis anytime prior to index date
3. Had a record of Inferior Vena Cava filter anytime prior to index date
4. Received anticoagulatory therapy within the 12-month period prior to index VTE encounter
5. Prescribed two different anticoagulants on the same index date
6. Had a record of pregnancy within the 9-month period prior to index date
7. Had a record of active cancer within the past 6 months of period prior to index date

Trial design

55,759 participants in 3 patient groups

Parenteral anticoagulant only

Description:

LMWH, UFH

Treatment:

Drug: Parenteral anticoagulant

Warfarin-based

Description:

Warfarin only + parenteral anticoagulant bridged warfarin

Treatment:

Drug: Warfarin

NOAC-based

Description:

NOAC only + parenteral anticoagulant bridged NOAC NOAC: apixaban, rivaroxaban, dabigatran, edoxaban

Treatment:

Drug: Rivaroxaban

Drug: Apixaban

Drug: Edoxaban

Drug: Dabigatran