Treatment Patterns Among Patients With Venous Thromboembolism in the United States

NCT ID: NCT05795062

Last Updated: 2024-11-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13945 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-10

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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apixaban

Patients treated with apixaban

apixaban

Intervention Type DRUG

patients treated with apixaban

warfarin

patients treated with warfarin

warfarin

Intervention Type DRUG

patients treated with warfarin

Interventions

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apixaban

patients treated with apixaban

Intervention Type DRUG

warfarin

patients treated with warfarin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B0661190

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Other Identifiers

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B0661190

Identifier Type: -

Identifier Source: org_study_id

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