Clinical trial NCT05795062: Treatment Patterns Among Patients With Venous Thromboembolism in the United States
Official title: Post-Discharge Treatment Patterns and Outcomes in Patients With Venous Thromboembolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2023-04-03
Enrollment: 13945
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are hospitalized for venous thromboembolism (VTE) and treated with apixaban or warfarin during the hospitalization. Patients will be identified through linkage of IQVIA's hospital charge data master database (CDM) with outpatient professional fee medical claims (Dx) and longitudinal prescription claims (LRx) databases during the period of July 2018 and August 2022.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Continued Treatment With Apixaban or Warfarin Following Discharge From the Hospital
timeFrame: From hospital discharge date through 30 days following discharge date (from the data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)
measure: Mean Number of Persistent Days
timeFrame: From the index date until the first of treatment discontinuation, treatment switch, or the end of follow-up, whichever occurred first (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)
measure: Percentage of Participants Who Discontinued Index Treatment at 6 Months Post-Discharge Index Date
timeFrame: At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)
measure: Percentage of Participants Who Discontinued Index Treatment at 12 Months Post-Discharge Index Date
timeFrame: At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)
measure: Percentage of Participants Who Switched From Index Treatment at 6 Months Post-Discharge Index Date
timeFrame: At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)
measure: Percentage of Participants Who Switched From Index Treatment at Month 12 Post-Discharge Index Date
timeFrame: At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)
measure: Median Time to Discontinuation From the Index Treatment
timeFrame: From initiation of index treatment post-discharge till its discontinuation (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)
measure: Median Time to Switch From the Index Treatment
timeFrame: From initiation of index treatment post-discharge till switch (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)
Secondary outcomes:
measure: Incidence Rate of Recurrent VTE Events
timeFrame: From first hospitalization discharge date to subsequent inpatient hospitalization for VTE (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)
measure: Median Time to Recurrent VTE
timeFrame: From first hospitalization discharge date to subsequent inpatient hospitalization for VTE (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)
measure: Incidence Rate of Major Bleeding Events
timeFrame: From first hospitalization discharge through first major bleeding event (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)
measure: Incidence Rate of Clinically Relevant Non-Major (CRNM) Bleeding Events
timeFrame: From first hospitalization discharge through first CRNM bleeding event (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: