Treatment Patterns Among Patients With Venous Thromboembolism in the United States
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| apixaban Patients treated with apixaban |
Drug: apixaban
patients treated with apixaban
|
| warfarin patients treated with warfarin |
Drug: warfarin
patients treated with warfarin
|
Outcome Measures
Primary Outcome Measures
- Inpatient Treatment [Up to 5.5 years]
Proportion of patients treated with apixaban or warfarin during hospitalization for venous thromboembolism.
- Post-hospitalization treatment patterns [Assessed from hospital discharge date to up to 30 days following discharge date]
Proportion of patients who continue on apixaban or warfarin following discharge from the hospital.
- Longterm treatment utilization [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]
Among patients who continue apixaban or warfarin post-discharge, assess treatment duration; including persistence, switch and discontinuation.
Secondary Outcome Measures
- Recurrent Venous Thromboembolism (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]
Patients with at least one hospitalization for recurrent VTE.
- 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]
Patients with at least one hospitalization for major bleeding.
- 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]
Proportion of patients with at least one inpatient or outpatient encounter for clinically relevant non-major bleeding.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer | 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:
Publications
None provided.- B0661190