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

Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05643885
• Other study ID #: B0661183
• Secondary ID: Heat map study
• Status: Active, not recruiting
• Start date: August 31, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. All-cause costs as well as costs associated with recurrent VTE, major bleeding, and clinically relevant nonmajor bleeding will be assessed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
United States	Pfizer Investigational	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total all-cause Healthcare Costs: Total Healthcare Costs Per Person Per Month (PPPM)		from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Primary	All-cause Healthcare Costs: Outpatient Pharmacy Costs Per Person Per Month		from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Primary	All-cause Healthcare Costs: Outpatient Medical Costs Per Person Per Month		from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Primary	All-cause Healthcare Costs: Hospitalization Costs Per Person Per Month		from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Primary	Recurrent Venous Thromboembolism (VTE) related Costs: Total costs Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Primary	Recurrent VTE related costs: Outpatient Medical Costs Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Primary	Recurrent VTE related Costs: Hospitalization Costs Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Primary	Major Bleeding Related Costs: Total Costs Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Primary	Major Bleeding Related Costs: Outpatient Medical Costs Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Primary	Major Bleeding Related Costs: Hospitalization Costs Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Primary	Clinically Relevant Non-Major Bleeding Related Costs: Total Costs Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Primary	Clinically relevant Non-Major Bleed Related Costs: Outpatient Medical Costs Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Primary	Clinically Relevant Non-Major Bleeding Related Costs: Hospitalization Costs Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary	All-cause Health Care Resource Utilization: Number of Hospitalizations Per Person Per Month		from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary	All-cause Health Care Resource Utilization: Number of Emergency Room Visits Per Person Per Month		from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary	All-cause Health Care Resource Utilization: Number of Outpatient Medical Visits Per Person Per Month		from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary	All-cause Health Care Resource utilization: Number of Prescription Fills Per Person Per Month		from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary	Recurrent Venous Thromboembolism (VTE) Related Health Care Resource Utilization: Number of Hospitalizations Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary	Recurrent VTE Related Health Care Resource Utilization: Number of Outpatient Medical Visits Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary	Recurrent VTE Related Health Care Resource Utilization: Number of Emergency Room Visits Per Patient Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary	Major Bleeding Related Health Care Resource Utilization: Number of Hospitalizations Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary	Major Bleeding Related Health Care Resource Utilization: Number of Outpatient Medical Visits Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary	Major Bleeding Related Health Care Resource Utilization: Number of Emergency Room Visits Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary	Clinically Relevant Non-Major Bleeding Related Health Care Resource Utilization: Number of Hospitalizations Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary	Clinically Relevant Non-Major Bleeding Related Health Care Resource Utilization: Number of Outpatient Medical Visits Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary	Clinically Relevant Non-Major Bleeding Health Care Resource Utilization: Number of Emergency Room Visits Per Person Per Month		from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months

External Links

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