N/A
N=13,945
Treatment Patterns Among Patients With Venous Thromboembolism in the United States
Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT05795062 ↗Enrolled (actual)
13,945
Serious AEs
—
Results posted
Nov 2024
Primary outcome: Primary: Number of Participants Who Continued Treatment With Apixaban or Warfarin Following Discharge From the Hospital — 11966; 1979 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- apixaban (Drug); warfarin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Continued Treatment With Apixaban or Warfarin Following Discharge From the Hospital |
11966; 1979 | — |
| PRIMARY Mean Number of Persistent Days |
233.5; 242.6 | — |
| PRIMARY Percentage of Participants Who Discontinued Index Treatment at 6 Months Post-Discharge Index Date |
50.5; 52.2 | — |
| PRIMARY Percentage of Participants Who Discontinued Index Treatment at 12 Months Post-Discharge Index Date |
72.9; 75.2 | — |
| PRIMARY Percentage of Participants Who Switched From Index Treatment at 6 Months Post-Discharge Index Date |
6.0; 20.9 | — |
| PRIMARY Percentage of Participants Who Switched From Index Treatment at Month 12 Post-Discharge Index Date |
7.1; 24.3 | — |
| PRIMARY Median Time to Discontinuation From the Index Treatment |
5.97; 5.67 | — |
| PRIMARY Median Time to Switch From the Index Treatment |
NA; NA | — |
| SECONDARY Incidence Rate of Recurrent VTE Events |
1.2; 2.5 | — |
| SECONDARY Median Time to Recurrent VTE |
NA; NA | — |
| SECONDARY Incidence Rate of Major Bleeding Events |
1.5; 2.0 | — |
| SECONDARY Incidence Rate of Clinically Relevant Non-Major (CRNM) Bleeding Events |
17.7; 21.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT05795062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.