Treatment Patterns Among Patients With Venous Thromboembolism in the United States

Venous Thromboembolism Clinical Trial

Official title:

Post-Discharge Treatment Patterns and Outcomes in Patients With Venous Thromboembolism

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05795062
• Other study ID #: B0661190
• Status: Active, not recruiting
• Start date: March 10, 2023
• 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 assess outpatient treatment patterns following hospitalization for venous thromboembolism (VTE). VTE is a condition that occurs when blood clot forms in the vein. This is a retrospective study (assessments on events that have already occurred) of healthcare claims from databases. The study sponsors will assess healthcare claim records of patients treated with either apixaban or warfarin. Assessment includes treatment persistence, switch, and stopping therapy, along with recurrent VTE and bleeding.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47029
• 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:

• inpatient hospitalization with primary discharge diagnosis of venous thromboembolism (VTE) (this is the index hospitalization)
• treatment with apixaban or warfarin during the hospitalization
• at least 18 years of age

Exclusion Criteria:

• Hospitalization for VTE within 6 months prior to the index hospitalization
• Diagnosis of atrial fibrillation/flutter or procedure for mechanical heart valve in the 6 months prior to the index hospitalization
• Procedure for inferior vena cava filter or diagnosis of pregnancy during the study period
• Prior use of oral anticoagulants or parenteral anticoagulants

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• apixaban
patients treated with apixaban
• warfarin
patients treated with warfarin

Locations

Country	Name	City	State
United States	Pfizer	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	Inpatient Treatment	Proportion of patients treated with apixaban or warfarin during hospitalization for venous thromboembolism.	Up to 5.5 years
Primary	Post-hospitalization treatment patterns	Proportion of patients who continue on apixaban or warfarin following discharge from the hospital.	Assessed from hospital discharge date to up to 30 days following discharge date
Primary	Longterm treatment utilization	Among patients who continue apixaban or warfarin post-discharge, assess treatment duration; including persistence, switch and discontinuation.	assessed from outpatient treatment start date up to the earliest of treatment discontinuation or switch, or end of study period. Assessed up to 4 years
Secondary	Recurrent Venous Thromboembolism (VTE)	Patients with at least one hospitalization for recurrent VTE.	assessed from outpatient treatment start date up to the earliest of treatment discontinuation or switch, or end of study period. Assessed up to 4 years
Secondary	Major bleeding	Patients with at least one hospitalization for major bleeding.	assessed from outpatient treatment start date up to the earliest of treatment discontinuation or switch, or end of study period. Assessed up to 4 years
Secondary	Clinically Relevant Non-major Bleeding	Proportion of patients with at least one inpatient or outpatient encounter for clinically relevant non-major bleeding.	assessed from outpatient treatment start date up to the earliest of treatment discontinuation or switch, or end of study period. Assessed up to 4 years

External Links

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