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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT05022563

Collaborator

(none)

100,000

Enrollment

Locations

Actual Duration (Days)

50000

Patients Per Site

50729.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism	Drug: Parenteral anticoagulant Drug: Warfarin Drug: Apixaban Drug: Rivaroxaban Drug: Dabigatran Drug: Edoxaban

Study Design

Study Type:

Observational

Actual Enrollment :

100000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Aug 31, 2021

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Parenteral anticoagulant only LMWH, UFH	Drug: Parenteral anticoagulant Parenteral anticoagulant only
Warfarin-based Warfarin only + parenteral anticoagulant bridged warfarin	Drug: Warfarin Warfarin-based
NOAC-based NOAC only + parenteral anticoagulant bridged NOAC NOAC: apixaban, rivaroxaban, dabigatran, edoxaban	Drug: Apixaban Apixaban Drug: Rivaroxaban Rivaroxaban Drug: Dabigatran Dabigatran Drug: Edoxaban Edoxaban

Arm

Intervention/Treatment

Parenteral anticoagulant only

LMWH, UFH

Drug: Parenteral anticoagulant

Parenteral anticoagulant only

Warfarin-based

Warfarin only + parenteral anticoagulant bridged warfarin

Drug: Warfarin

Warfarin-based

NOAC-based

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

Drug: Apixaban

Apixaban

Drug: Rivaroxaban

Rivaroxaban

Drug: Dabigatran

Dabigatran

Drug: Edoxaban

Edoxaban

Outcome Measures

Primary Outcome Measures

Treatment interruption [From index date to follow-up period (up to a maximum duration of 81 months)]
Treatment interruption is defined as when a patient has a gap with no new treatment within 30 days of the estimated end of supply, but subsequently restarts the index treatment after this period.
Treatment switch [From index date to follow-up period (up to a maximum duration of 81 months)]
Treatment switching is defined as a prescription of another anticoagulant therapy that is started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch).
Treatment discontinuation [From index date to follow-up period (up to a maximum duration of 81 months)]
Complete discontinuation; no reinitiation
Median overall treatment duration for index treatment [From index date to follow-up period (up to a maximum duration of 81 months)]
Event rate of major bleeding [From index date to follow-up period (up to a maximum duration of 81 months)]

Secondary Outcome Measures

Clinical events preceding first treatment change [From index date to follow-up period (up to maximum duration of 81 months)]
Clinical event preceding first treatment change will be defined as occurrence of any event - major bleeding, complication of VTE, thromboembolism, major surgery, new diagnosis of cancer, kidney function change, or liver function change - within 30 days before treatment interruption, switch, or discontinuation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Incident VTE diagnosis in an inpatient or outpatient setting between 1 Mar 2013 and 30 Jun 2019
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)
Aged ≥18 years at index date

Exclusion Criteria:

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