N/A
Completed N=55,759
Treatment Patterns and Bleeding Risk of Anticoagulants in Patients With Venous Thromboembolism in Korea
Source: ClinicalTrials.gov NCT05022563 ↗Enrolled (actual)
55,759
Serious AEs
—
Results posted
Aug 2023
Primary outcomePrimary: Number of Participants With Interruption in Index Anticoagulant Treatment — 3429; 8169; 965; 492 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Interruption in Index Anticoagulant Treatment |
3429; 8169; 965; 492; 439; 5973 | — |
| PRIMARY Time to Treatment Interruption |
163; 129; 86; 137; 130; 128 | — |
| PRIMARY Number of Participants Who Switched to Another Anticoagulant Therapy |
1541; 1273; 319; 276; 204; 1777 | — |
| PRIMARY Time to Treatment Switch |
57; 179; 66; 105; 87; 99 | — |
| PRIMARY Number of Participants Who Completely Discontinued Index Anticoagulant Treatment |
4707; 19826; 2828; 1028; 1164; 14170 | — |
| PRIMARY Time to Treatment Discontinuation |
129; 119; 84; 134; 154; 119 | — |
| PRIMARY Overall Index Anticoagulant Treatment Duration |
139; 140; 96; 137; 164; 128 | — |
| PRIMARY Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months |
6313; 19848; 2390; 1225; 1395; 14037 | — |
| PRIMARY Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months |
4393; 10557; 1213; 606; 817; 7209 | — |
| PRIMARY Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption |
27; 53; 5; 2; 2; 42 | — |
| PRIMARY Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding |
5; 0; 0; 1; 4; 5 | — |
| PRIMARY Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE |
12; 0; 0; 0; 11; 1 | — |
| PRIMARY Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism |
59; 6; 3; 2; 48; 12 | — |
| PRIMARY Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery |
13; 0; 2; 1; 10; 14 | — |
| PRIMARY Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event |
13; 1; 1; 0; 11; 6 | — |
| PRIMARY Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change |
13; 1; 0; 0; 12; 5 | — |
| PRIMARY Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change |
36; 3; 4; 1; 28; 10 | — |
| PRIMARY Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation |
42; 118; 13; 7; 5; 90 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05022563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.