Clinical trial NCT05022563: Treatment Patterns and Bleeding Risk of Anticoagulants in Patients With Venous Thromboembolism in Korea
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Venous thromboembolism
anticoagulant
treatment pattern
bleed
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-08-26
Enrollment: 55759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with venous thromboembolism from the South Korea's Health Insurance Review and Assessment Service (HIRA) database between Mar 1, 2013 and Jun 30, 2019

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Interruption in Index Anticoagulant Treatment
timeFrame: From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Time to Treatment Interruption
timeFrame: From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Number of Participants Who Switched to Another Anticoagulant Therapy
timeFrame: From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Time to Treatment Switch
timeFrame: From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Number of Participants Who Completely Discontinued Index Anticoagulant Treatment
timeFrame: From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Time to Treatment Discontinuation
timeFrame: From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Overall Index Anticoagulant Treatment Duration
timeFrame: From index date up to the earliest of treatment interruption, switch, or discontinuation; during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months
timeFrame: Within 3 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months
timeFrame: Within 6 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption
timeFrame: Within 30 days before treatment interruption during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
timeFrame: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
timeFrame: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
timeFrame: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
timeFrame: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
timeFrame: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
timeFrame: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
timeFrame: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
measure: Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation
timeFrame: Within 30 days before treatment discontinuation during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Suwon-si
country: Korea, Republic of
facility: Sungkyunkwan University
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: