Venous ThromboembolismNCT05022563

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

An observational study of Venous Thromboembolism, run by Pfizer at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Venous Thromboembolism
What is being tested?: Parenteral anticoagulant, Warfarin and Apixaban
How many people: 55,759 participants
Where: 2 sitesSouth Korea
Study dates: 31 Aug 2021to 30 Sep 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

Seoul National University Bundang Hospital
Seongnam-si
Sungkyunkwan University
Suwon

Other trials in South Korea

About this study

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

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
Being tested: Parenteral anticoagulant, Warfarin, Apixaban, Rivaroxaban, Dabigatran
Keywords: Venous thromboembolism, anticoagulant, treatment pattern, bleed
Medical subject headings: Venous Thromboembolism, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Parenteral anticoagulantDrug
Parenteral anticoagulant only
WarfarinDrug
Warfarin-based
ApixabanDrug
Apixaban
RivaroxabanDrug
Rivaroxaban
DabigatranDrug
Dabigatran
EdoxabanDrug
Edoxaban

Study groups in NCT05022563
Study group	Role	What they receive
Parenteral anticoagulant only		LMWH, UFH Receives: Drug: Parenteral anticoagulant
Warfarin-based		Warfarin only + parenteral anticoagulant bridged warfarin Receives: Drug: Warfarin
NOAC-based		NOAC only + parenteral anticoagulant bridged NOAC NOAC: apixaban, rivaroxaban, dabigatran, edoxaban Receives: Drug: Apixaban; Drug: Rivaroxaban; Drug: Dabigatran; Drug: Edoxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Interruption in Index Anticoagulant Treatment
Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Measured: 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)
Time to Treatment Interruption
Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The time to treatment interruption was defined as the period from the index date to the date of treatment interruption. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Measured: 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)
Number of Participants Who Switched to Another Anticoagulant Therapy
Treatment switching was defined as a prescription of another anticoagulant therapy that was 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). The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Measured: 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)
Time to Treatment Switch
Treatment switching was defined as a prescription of another anticoagulant therapy that was 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). The time to treatment switch was defined as the period from the index date to the date of treatment switch. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Measured: 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)
Number of Participants Who Completely Discontinued Index Anticoagulant Treatment
Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Measured: 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)
Time to Treatment Discontinuation
Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The time to treatment discontinuation was defined as the period from the index date to the date of treatment discontinuation. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Measured: 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)
Overall Index Anticoagulant Treatment Duration
Overall anticoagulant treatment duration was defined as the time period from the index date to the earliest of treatment interruption, switch, or discontinuation. Treatment interruption: when a participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after this period of 30 days. Treatment switching: a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Treatment discontinuation: when a participant who ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Measured: 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)
Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months
Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event.
Measured: 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)
Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months
Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event.
Measured: 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)
Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment interruption. Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event.
Measured: 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)
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "major bleeding" are reported.
Measured: 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)
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "complications of VTE" are reported.
Measured: 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)
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "thromboembolism" are reported.
Measured: 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)
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "major surgery" are reported.
Measured: 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)
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "cancer-related event" are reported among participants without active cancer. Data not collected and reported for participants with active because all participants already had cancer.
Measured: 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)
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "kidney function change" are reported.
Measured: 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)
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "liver function change" are reported.
Measured: 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)
Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment discontinuation. Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 202130 Sep 2021

First posted26 Aug 2021
Study start31 Aug 2021
Primary completion30 Sep 2021
Study completion30 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 55,759 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05022563
Sponsor's protocol ID: X9001305
Other IDs: VTE HIRA Study
Status last verified: Sep 2022
First submitted: 20 Aug 2021
Last updated: 3 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Venous Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05022563
Acronym / sponsor ID: X9001305
Conditions: Venous Thromboembolism
Keywords: Venous thromboembolism, anticoagulant, treatment pattern, bleed
Study type: Observational
Recruitment status: Completed
Enrolment: 55,759 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 31 Aug 2021 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 26 Aug 2021 (actual)
Results: Posted 3 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
Parenteral anticoagulant only	–	Drug: Parenteral anticoagulantLMWH, UFH
Warfarin-based	–	Drug: WarfarinWarfarin only + parenteral anticoagulant bridged warfarin
NOAC-based	–	Drug: Apixaban, Drug: Rivaroxaban, Drug: Dabigatran, Drug: EdoxabanNOAC only + parenteral anticoagulant bridged NOAC NOAC: apixaban, rivaroxaban, dabigatran, edoxaban

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Parenteral anticoagulantParenteral anticoagulant only	Drug	Parenteral anticoagulant only
WarfarinWarfarin-based	Drug	Warfarin-based
ApixabanApixaban	Drug	NOAC-based
RivaroxabanRivaroxaban	Drug	NOAC-based
DabigatranDabigatran	Drug	NOAC-based
EdoxabanEdoxaban	Drug	NOAC-based

Primary outcome

Number of Participants With Interruption in Index Anticoagulant Treatment
Time frame: 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)
Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Time to Treatment Interruption
Time frame: 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)
Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The time to treatment interruption was defined as the period from the index date to the date of treatment interruption. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Number of Participants Who Switched to Another Anticoagulant Therapy
Time frame: 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)
Treatment switching was defined as a prescription of another anticoagulant therapy that was 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). The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Time to Treatment Switch
Time frame: 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)
Treatment switching was defined as a prescription of another anticoagulant therapy that was 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). The time to treatment switch was defined as the period from the index date to the date of treatment switch. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Number of Participants Who Completely Discontinued Index Anticoagulant Treatment
Time frame: 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)
Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Time to Treatment Discontinuation
Time frame: 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)
Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The time to treatment discontinuation was defined as the period from the index date to the date of treatment discontinuation. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Overall Index Anticoagulant Treatment Duration
Time frame: 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)
Overall anticoagulant treatment duration was defined as the time period from the index date to the earliest of treatment interruption, switch, or discontinuation. Treatment interruption: when a participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after this period of 30 days. Treatment switching: a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Treatment discontinuation: when a participant who ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event.
Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months
Time frame: 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)
Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event.
Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months
Time frame: 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)
Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event.
Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption
Time frame: 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)
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment interruption. Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event.
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
Time frame: 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)
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "major bleeding" are reported.
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
Time frame: 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)
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "complications of VTE" are reported.
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
Time frame: 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)
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "thromboembolism" are reported.
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
Time frame: 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)
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "major surgery" are reported.
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
Time frame: 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)
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "cancer-related event" are reported among participants without active cancer. Data not collected and reported for participants with active because all participants already had cancer.
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
Time frame: 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)
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "kidney function change" are reported.
Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
Time frame: 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)
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event "liver function change" are reported.
Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation
Time frame: 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)
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment discontinuation. Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event.

Results and safety

Results posted to the registry on 3 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Warfarin-Based Therapy	11,208	11,208
Non-vitamin K Antagonist Oral Anticoagulants (NOAC)-Based Therapy: Apixaban	5,047	5,047
NOAC-Based Therapy: Dabigatran	2,103	2,103
NOAC-Based Therapy: Edoxaban	2,342	2,342
NOAC-Based Therapy: Rivaroxaban	26,276	26,276
Parenteral Anticoagulants (PAC) Only	8,783	8,783

Primary outcome: Number of Participants With Interruption in Index Anticoagulant Treatment

Time frame: 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). Count of participants. Unit: Participants

Measure	Warfarin-Based Therapy n = 11208	NOAC-Based Therapy n = 35768	NOAC-Based Therapy: Apixaban n = 5047	NOAC-Based Therapy: Dabigatran n = 2103	NOAC-Based Therapy: Edoxaban n = 2342	NOAC-Based Therapy: Rivaroxaban n = 26276	PAC Only n = 8783
Without Active Cancer	3429	8169	965	492	439	5973	1226
With Active Cancer	172	961	115	51	38	728	401

Population analysed: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as one entity, while individual NOAC results discriminated between each NOAC, therefore total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Here, "Number Analyzed" signifies participants evaluable for specified rows.

Primary outcome: Time to Treatment Interruption

Measure	Warfarin-Based Therapy n = 3601	NOAC-Based Therapy n = 9130	NOAC-Based Therapy: Apixaban n = 1080	NOAC-Based Therapy: Dabigatran n = 543	NOAC-Based Therapy: Edoxaban n = 477	NOAC-Based Therapy: Rivaroxaban n = 6701	PAC Only n = 1627
Without Active Cancer	163 (50 to 343)	129 (37 to 189)	86 (16 to 181)	137 (56 to 188)	130 (42 to 189)	128 (38 to 188)	3 (1 to 10)
With Active Cancer	129 (50 to 270)	137 (51 to 188)	123 (59 to 186)	119 (58 to 188)	159 (30 to 199)	134 (49 to 187)	61 (7 to 160)

Population analysed: All eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure with interruption event;"Number Analyzed": participants evaluable for specified rows.

Primary outcome: Number of Participants Who Switched to Another Anticoagulant Therapy

Time frame: 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). Count of participants. Unit: Participants

Measure	Warfarin-Based Therapy n = 11208	NOAC-Based Therapy n = 35768	NOAC-Based Therapy: Apixaban n = 5047	NOAC-Based Therapy: Dabigatran n = 2103	NOAC-Based Therapy: Edoxaban n = 2342	NOAC-Based Therapy: Rivaroxaban n = 26276	PAC Only n = 8783
Without Active Cancer	1541	1273	319	276	204	1777	535
With Active Cancer	144	173	33	30	26	208	208

Primary outcome: Time to Treatment Switch

Measure	Warfarin-Based Therapy n = 1685	NOAC-Based Therapy n = 1446	NOAC-Based Therapy: Apixaban n = 352	NOAC-Based Therapy: Dabigatran n = 306	NOAC-Based Therapy: Edoxaban n = 230	NOAC-Based Therapy: Rivaroxaban n = 1985	PAC Only n = 743
Without Active Cancer	57 (21 to 182)	179 (53 to 199)	66 (24 to 181)	105 (32 to 189)	87 (25 to 189)	99 (23 to 189)	27 (19 to 39)
With Active Cancer	36 (13 to 99)	76 (20 to 172)	44 (14 to 109)	60 (30 to 174)	98 (28 to 150)	53 (21 to 149)	49 (27 to 102)

Population analysed: All eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure with switch event; "Number Analyzed": participants evaluable for specified rows.

Adverse events

Time frame: Adverse events were not planned to be collected hence time frame was not applicable. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Warfarin-Based Therapy	0 of 0	0 of 0
NOAC-Based Therapy: Apixaban	0 of 0	0 of 0
NOAC-Based Therapy: Dabigatran	0 of 0	0 of 0
NOAC-Based Therapy: Edoxaban	0 of 0	0 of 0
NOAC-Based Therapy: Rivaroxaban	0 of 0	0 of 0
PAC Only	0 of 0	0 of 0

Limitations and caveats (from the sponsor): Phase 2 was not conducted due to insufficient statistical power that would lead to small and imbalanced sample sizes in comparison groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Venous Thromboembolism, run by Pfizer at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Interruption in Index Anticoagulant Treatment (time frame: 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)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05022563.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.