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

• Sponsor: Pfizer (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05643885
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 10,000
• Location: 1
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 1435.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thromboembolism

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Cost Comparison Between Apixaban and Low Molecular Weight Heparin (LMWH) Among Venous Thromboembolism (VTE) Cancer Patients
• Actual Study Start Date: Aug 31, 2022
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
apixaban patients treated with apixaban
Low molecular weight heparin (LMWH) patients treated with low molecular weight heparin

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

6. 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]

7. 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]

8. 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]

9. 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]

10. 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]

11. 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]

12. 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]

13. 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 Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

6. 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]

7. 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]

8. 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]

9. 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]

10. 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]

11. 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]

12. 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]

13. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational	New York	New York	United States	10017

Sponsors and Collaborators

• Pfizer
• Bristol-Myers Squibb

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05643885
• Other Study ID Numbers: B0661183
• First Posted: Dec 9, 2022
• Last Update Posted: Dec 9, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Thromboembolism; Venous Thromboembolism

Study Results

No Results Posted as of Dec 9, 2022