ThromboembolismNCT05643885

A Study to Compare Health Care Costs Between Apixaban and Low Molecular Weight Heparin in Patients With Venous Thromboembolism and Cancer

An observational study of Thromboembolism, run by Pfizer at 1 site in United States.

Completed

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

Trial summary

The purpose of this study is to evaluate the health care resource utilization and costs associated with treating patients diagnosed with cancer and venous thromboembolism with apixaban or low molecular weight heparin. This is a retrospective database analysis of health care claims data. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Thromboembolism
How many people: 7,304 participants
Where: 1 siteUnited States
Study dates: 31 Aug 2022to 30 Aug 2024
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 with active cancer who are newly diagnosed with venous thromboembolism (VTE) and treated with apixaban or low molecular weight heparin within 30 days following the VTE. Patients will be identified from the PharMetrics Plus health care claims database between the period of January 2017 and October 2021 if they have a VTE diagnosis and claim for apixaban or low molecular weight heparin during this time.

Who may be able to join

Venous thromboembolism (VTE) diagnosis between January 1 2017 and October 31 2021
Evidence of active cancer
At least 1 claim for apixaban or low molecular weight heparin (LMWH)
Age 18 years or older

Who cannot join

diagnosis of atrial fibrillation/flutter
procedure for mechanical heart valve or inferior vena cava filter
VTE diagnosis in the baseline period
anticoagulant therapy in the baseline period
pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational
New York, New York, 10017

Other trials in United States

About this study

Official title: Cost Comparison Between Apixaban and Low Molecular Weight Heparin (LMWH) Among Venous Thromboembolism (VTE) Cancer Patients

Conditions: Thromboembolism
Medical subject headings: Thromboembolism

What participants receive

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

Study groups in NCT05643885
Study group	Role	What they receive
apixaban		patients treated with apixaban
Low molecular weight heparin (LMWH)		patients treated with low molecular weight heparin

What is being measured

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

Mean All-Cause Healthcare Costs Per Participant Per Month (PPPM) for VTE Events
The all-cause healthcare cost for VTE event was defined as the sum of total cost associated with the total inpatient, total outpatient, and total pharmacy costs for the VTE event. Costs were converted to 2021 United States dollars (USD) using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Outpatient Pharmacy Costs PPPM for VTE Events
The all-cause healthcare outpatient pharmacy cost for VTE event was defined as the total cost associated with the outpatient pharmacy costs for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Outpatient Medical Costs PPPM for VTE Events
The all-cause healthcare outpatient medical cost for VTE event was defined as the total cost associated with the outpatient medical costs (excluding pharmacy costs) for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Hospitalization Costs PPPM for VTE Events
The all-cause healthcare hospitalization cost for VTE event was defined as the cost associated with the inpatient hospitalization for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Costs PPPM for Recurrent VTE Events
Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (international classification of diseases, tenth revision, clinical modification [ICD-10-CM] diagnosis codes). Recurrent VTE all cause healthcare costs were defined as the costs associated with the first recurrent VTE hospitalization and all subsequent VTE costs in the inpatient (primary or secondary diagnosis) or outpatient (any position) setting. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Outpatient Medical Costs PPPM for Recurrent VTE Events
Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). Recurrent VTE outpatient medical costs included costs associated with physician office visits, emergency room visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Hospitalization Costs PPPM for Recurrent VTE Events
Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). The all-cause healthcare hospitalization cost for recurrent VTE event was defined as the cost associated with the inpatient hospitalization for the recurrent VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Costs PPPM for Major Bleeding Related VTE Events
Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including gastrointestinal (GI) bleeding, intracranial hemorrhage (ICH), and other major bleeding. Major bleeding-related all cause healthcare costs were defined as costs associated with the first major bleeding hospitalization plus all subsequent bleeding costs occurring in the inpatient (primary or secondary diagnosis) or outpatient setting (any position). Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Outpatient Medical Costs PPPM for Major Bleeding Related VTE Events
Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH and other major bleeding. Major bleeding-related all cause outpatient medical costs were major bleeding related outpatient costs associated with physician office visits, emergency room visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Hospitalization Costs PPPM for Major Bleeding Related VTE Events
Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH, and other major bleeding. Major bleeding-related all cause healthcare costs were defined as costs associated with the first major bleeding hospitalization plus all subsequent bleeding costs occurring in the inpatient (primary or secondary diagnosis). Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Costs PPPM for Clinically Relevant Non-Major (CRNM) Bleeding Related VTE Events
CRNM bleeding-related all cause healthcare costs were combination of bleeding related inpatient and outpatient costs. CRNM bleeding was defined as an inpatient encounter with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM GI bleeding or other non-critical types of bleeding. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Outpatient Medical Costs PPPM for CRNM Bleeding Related VTE Events
CRNM bleeding was defined as an inpatient encounter with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM GI bleeding or other non-critical types of bleeding. CRNM bleeding all cause outpatient medical costs were major bleeding related outpatient costs associated with physician office visits, emergency room (ER) visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Hospitalization Costs PPPM for CRNM Bleeding Related VTE Events
CRNM bleeding was defined as an inpatient encounter with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM GI bleeding or other non-critical types of bleeding. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months

Secondary outcomes (9)

Mean Number of Hospitalizations Per Participant Per Month (PPPM) for VTE Events
Mean number of hospitalizations PPPM for VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Outpatient Medical Visits PPPM for VTE Events
Mean number of outpatient medical visits PPPM for VTE events are reported in this outcome measure. Outpatient visits included physician office visits, ER visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Prescription Fills PPPM for VTE Events
Mean number of prescription fills PPPM for VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Hospitalizations PPPM for Recurrent VTE Events
Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). Mean number of hospitalizations PPPM for recurrent VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Outpatient Medical Visits PPPM for Recurrent VTE Events
Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). Outpatient visits included physician office visits, ER only visits, laboratory or pathology visits, radiology, and surgical services and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Hospitalizations PPPM for Major Bleeding Related VTE Events
Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH and other major bleeding. Mean number of hospitalizations PPPM for recurrent VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Outpatient Medical Visits PPPM for Major Bleeding Related VTE Events
Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH and other major bleeding. Outpatient visits included physician office visits, ER only visits, laboratory or pathology visits, radiology, and surgical services and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Hospitalizations PPPM for CRNM Bleeding Related VTE Events
CRNM bleeding was defined as an inpatient encounter with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM GI bleeding or other non-critical types of bleeding. Mean number of hospitalizations PPPM for recurrent VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Outpatient Medical Visits PPPM for CRNM Bleeding Related VTE Events
CRNM bleeding was defined as an inpatient encounter with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM GI bleeding or other non-critical types of bleeding. Outpatient visits included physician office visits, ER only visits, laboratory or pathology visits, radiology, and surgical services and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.
Measured: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months

Timeline

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

31 Aug 202230 Aug 2024

First posted9 Dec 2022
Study start31 Aug 2022
Primary completion30 Aug 2024
Study completion30 Aug 2024

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 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: 7,304 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05643885
Sponsor's protocol ID: B0661183
Other IDs: NCT05643885
Status last verified: Sep 2025
First submitted: 17 Nov 2022
Last updated: 20 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cost Comparison Between Apixaban and Low Molecular Weight Heparin (LMWH) Among Venous Thromboembolism (VTE) Cancer Patients
ClinicalTrials.gov ID: NCT05643885
Acronym / sponsor ID: B0661183
Conditions: Thromboembolism
Study type: Observational
Recruitment status: Completed
Enrolment: 7,304 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: 31 Aug 2022 (actual)
Primary completion: 30 Aug 2024 (actual)
Study completion: 30 Aug 2024 (actual)
First posted: 9 Dec 2022 (actual)
Results: Posted 20 Oct 2025

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: 2

Arm	Type	Receives
apixaban	–	–patients treated with apixaban
Low molecular weight heparin (LMWH)	–	–patients treated with low molecular weight heparin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with active cancer who are newly diagnosed with venous thromboembolism (VTE) and treated with apixaban or low molecular weight heparin within 30 days following the VTE. Patients will be identified from the PharMetrics Plus health care claims database between the period of January 2017 and October 2021 if they have a VTE diagnosis and claim for apixaban or low molecular weight heparin during this time.

Key inclusion criteria (4 listed)

Venous thromboembolism (VTE) diagnosis between January 1 2017 and October 31 2021
Evidence of active cancer
At least 1 claim for apixaban or low molecular weight heparin (LMWH)
Age 18 years or older

Key exclusion criteria (5 listed)

diagnosis of atrial fibrillation/flutter
procedure for mechanical heart valve or inferior vena cava filter
VTE diagnosis in the baseline period
anticoagulant therapy in the baseline period
pregnancy

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

Primary outcome

Mean All-Cause Healthcare Costs Per Participant Per Month (PPPM) for VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
The all-cause healthcare cost for VTE event was defined as the sum of total cost associated with the total inpatient, total outpatient, and total pharmacy costs for the VTE event. Costs were converted to 2021 United States dollars (USD) using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Mean All-Cause Healthcare Outpatient Pharmacy Costs PPPM for VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
The all-cause healthcare outpatient pharmacy cost for VTE event was defined as the total cost associated with the outpatient pharmacy costs for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Mean All-Cause Healthcare Outpatient Medical Costs PPPM for VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
The all-cause healthcare outpatient medical cost for VTE event was defined as the total cost associated with the outpatient medical costs (excluding pharmacy costs) for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Mean All-Cause Healthcare Hospitalization Costs PPPM for VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
The all-cause healthcare hospitalization cost for VTE event was defined as the cost associated with the inpatient hospitalization for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Mean All-Cause Healthcare Costs PPPM for Recurrent VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (international classification of diseases, tenth revision, clinical modification [ICD-10-CM] diagnosis codes). Recurrent VTE all cause healthcare costs were defined as the costs associated with the first recurrent VTE hospitalization and all subsequent VTE costs in the inpatient (primary or secondary diagnosis) or outpatient (any position) setting. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Mean All-Cause Healthcare Outpatient Medical Costs PPPM for Recurrent VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). Recurrent VTE outpatient medical costs included costs associated with physician office visits, emergency room visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Mean All-Cause Healthcare Hospitalization Costs PPPM for Recurrent VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). The all-cause healthcare hospitalization cost for recurrent VTE event was defined as the cost associated with the inpatient hospitalization for the recurrent VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Mean All-Cause Healthcare Costs PPPM for Major Bleeding Related VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including gastrointestinal (GI) bleeding, intracranial hemorrhage (ICH), and other major bleeding. Major bleeding-related all cause healthcare costs were defined as costs associated with the first major bleeding hospitalization plus all subsequent bleeding costs occurring in the inpatient (primary or secondary diagnosis) or outpatient setting (any position). Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Mean All-Cause Outpatient Medical Costs PPPM for Major Bleeding Related VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH and other major bleeding. Major bleeding-related all cause outpatient medical costs were major bleeding related outpatient costs associated with physician office visits, emergency room visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Mean All-Cause Hospitalization Costs PPPM for Major Bleeding Related VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH, and other major bleeding. Major bleeding-related all cause healthcare costs were defined as costs associated with the first major bleeding hospitalization plus all subsequent bleeding costs occurring in the inpatient (primary or secondary diagnosis). Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Mean All-Cause Healthcare Costs PPPM for Clinically Relevant Non-Major (CRNM) Bleeding Related VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
CRNM bleeding-related all cause healthcare costs were combination of bleeding related inpatient and outpatient costs. CRNM bleeding was defined as an inpatient encounter with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM GI bleeding or other non-critical types of bleeding. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Mean All-Cause Outpatient Medical Costs PPPM for CRNM Bleeding Related VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
CRNM bleeding was defined as an inpatient encounter with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM GI bleeding or other non-critical types of bleeding. CRNM bleeding all cause outpatient medical costs were major bleeding related outpatient costs associated with physician office visits, emergency room (ER) visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.
Mean All-Cause Hospitalization Costs PPPM for CRNM Bleeding Related VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
CRNM bleeding was defined as an inpatient encounter with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM GI bleeding or other non-critical types of bleeding. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.

9 secondary outcomes

Mean Number of Hospitalizations Per Participant Per Month (PPPM) for VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Outpatient Medical Visits PPPM for VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Prescription Fills PPPM for VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Hospitalizations PPPM for Recurrent VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Outpatient Medical Visits PPPM for Recurrent VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Hospitalizations PPPM for Major Bleeding Related VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Outpatient Medical Visits PPPM for Major Bleeding Related VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Hospitalizations PPPM for CRNM Bleeding Related VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Outpatient Medical Visits PPPM for CRNM Bleeding Related VTE Events
Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months

Results and safety

Results posted to the registry on 20 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Apixaban	4,299	4,299
LMWH	3,005	3,005

Primary outcome: Mean All-Cause Healthcare Costs Per Participant Per Month (PPPM) for VTE Events

Time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months. Mean (Standard Deviation). Unit: USD per participant per month

Measure	Apixaban n = 4288	LMWH n = 3022
Value	16420 (23354)	21312 (27337)

Apixaban vs LMWH: p <0.0001, Weighted t-test

Population analysed: Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized inverse probability of treatment weighting (IPTW). Hence, numbers are different here from those presented in participant flow and baseline section.

Primary outcome: Mean All-Cause Healthcare Outpatient Pharmacy Costs PPPM for VTE Events

Measure	Apixaban n = 4288	LMWH n = 3022
Value	2452 (5376)	2654 (4701)

Apixaban vs LMWH: p <0.0001, Weighted t-test

Population analysed: Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW. Hence, numbers are different here from those presented in participant flow and baseline section.

Primary outcome: Mean All-Cause Healthcare Outpatient Medical Costs PPPM for VTE Events

Measure	Apixaban n = 4288	LMWH n = 3022
Value	8028 (11644)	10042 (12759)

Apixaban vs LMWH: p <0.0001, Weighted t-test

Population analysed: Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW. Hence, numbers are different here from those presented in participant flow and baseline section.

Primary outcome: Mean All-Cause Healthcare Hospitalization Costs PPPM for VTE Events

Measure	Apixaban n = 4288	LMWH n = 3022
Value	5940 (17512)	8616 (22667)

Apixaban vs LMWH: p <0.0001, Weighted t-test

Population analysed: Analysis population included all participants whose data were included and observed in the study. Here, "Overall Number of Participants Analyzed" reflects the pseudo-population created using stabilized IPTW. Hence, numbers are different here from those presented in participant flow and baseline section.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Not applicable as adverse events and all-cause mortality were not planned to be assessed or monitored during this study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Apixaban	0 of 0	0 of 0	0
LMWH	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
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

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

Questions about this trial

What is this clinical trial studying?

An observational study of Thromboembolism, run by Pfizer at 1 site in United States.

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 4 inclusion and 5 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 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 20 Oct 2025). 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?

Mean All-Cause Healthcare Costs Per Participant Per Month (PPPM) for VTE Events (time frame: From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months). The study lists 13 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 NCT05643885.

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 20 Oct 2025.