NCT05022563

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

Treatment Patterns and Clinical Outcomes Among Venous Thromboembolism Patients Treated With Anticoagulants After the Entry of Non-vitamin K Antagonist Oral Anticoagulants in Korea

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55,759 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Parenteral anticoagulant	Parenteral anticoagulant only
DRUG	Warfarin	Warfarin-based
DRUG	Apixaban	Apixaban
DRUG	Rivaroxaban	Rivaroxaban
DRUG	Dabigatran	Dabigatran
DRUG	Edoxaban	Edoxaban

Timeline

• Start date: 2021-08-31
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2021-08-26
• Last updated: 2023-08-03
• Results posted: 2023-08-03

Locations

2 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study