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Completed

NCT Number: NCT05795062

Treatment Patterns Among Patients With Venous Thromboembolism in the United States

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

New York, 10017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban

Drug

patients treated with apixaban

Warfarin

Drug

patients treated with warfarin

Primary outcomes

  1. Number of Participants Who Continued Treatment With Apixaban or Warfarin Following Discharge From the Hospital

    Time frame: 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)

    Following discharge from inpatient hospitalization, participants who continued apixaban or warfarin, respectively, in the outpatient setting (with outpatient treatment claim occurring on or within 30-days following the hospital discharge date) were identified.

  2. Mean Number of Persistent Days

    Time frame: 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)

    Persistent days was defined as the number of days from the index date until the first of the following: treatment discontinuation, treatment switch, or the end of follow-up. Treatment index date: date of first outpatient apixaban or warfarin claim.

  3. Percentage of Participants Who Discontinued Index Treatment at 6 Months Post-Discharge Index Date

    Time frame: At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

    Discontinuation was defined as greater than or equal to (>=) 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim.

  4. Percentage of Participants Who Discontinued Index Treatment at 12 Months Post-Discharge Index Date

    Time frame: At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

    Discontinuation was defined as >= 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim.

  5. Percentage of Participants Who Switched From Index Treatment at 6 Months Post-Discharge Index Date

    Time frame: At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

    Participants were considered to have switched if they filled a prescription for oral anticoagulant (OAC) other than apixaban or warfarin, respectively (identified through national drug codes [NDC] codes in longitudinal prescription claims [LRx]) or for parenteral anticoagulant (PAC) within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim.

  6. Percentage of Participants Who Switched From Index Treatment at Month 12 Post-Discharge Index Date

    Time frame: At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

    Participants were considered to have switched if they filled a prescription for OAC other than apixaban or warfarin, respectively (identified through NDC codes in LRx) or for PAC within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim.

  7. Median Time to Discontinuation From the Index Treatment

    Time frame: 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)

    Time from treatment index date to discontinuation date was described in this outcome measure. Discontinuation was defined as >= 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim.

  8. Median Time to Switch From the Index Treatment

    Time frame: 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)

    Time from treatment index date to treatment switch date was described in this outcome measure. Participants were considered to have switched if they filled a prescription for OAC other than apixaban or warfarin, respectively (identified through NDC codes in LRx) or for PAC within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim.

Secondary outcomes

  1. Incidence Rate of Recurrent VTE Events

    Time frame: 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)

    Recurrent VTE was defined as inpatient hospitalization with a primary diagnosis of VTE occurring 7 or more days after the first hospitalization discharge date. The date of the first observed event was flagged. Incidence rate was defined as the number of events (recurrent VTE) per 100 participant years. Treatment index date: date of first outpatient apixaban or warfarin claim.

  2. Median Time to Recurrent VTE

    Time frame: 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)

    Recurrent VTE was defined as inpatient hospitalization with a primary diagnosis of VTE occurring 7 or more days after the first hospitalization discharge date. The date of the first observed event was flagged. Treatment index date: date of first outpatient apixaban or warfarin claim.

  3. Incidence Rate of Major Bleeding Events

    Time frame: 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)

    Major bleeding was defined as inpatient hospitalization with primary diagnosis of gastro-intestinal bleeding, intracranial hemorrhage (ICH) or other major bleeding. Incidence rate was defined as the number of events (major bleeding) per 100 participant years. Treatment index date: date of first outpatient apixaban or warfarin claim.

  4. Incidence Rate of Clinically Relevant Non-Major (CRNM) Bleeding Events

    Time frame: 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)

    CRNM bleeding was defined as inpatient hospitalization with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM gastrointestinal (GI) bleeding or other non-critical types of bleeding. Incidence rate was defined as the number of events (CRNM bleeding) per 100 participant years.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2023
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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