Treatment Patterns Among Patients With Venous Thromboembolism in the United States

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Venous Thromboembolism

Being tested

apixaban, warfarin

Medical subject headings

Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• apixabanDrug

  patients treated with apixaban

• warfarinDrug

  patients treated with warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

   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.

   Measured: 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)

2. Mean Number of Persistent Days

   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.

   Measured: 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)

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

   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.

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

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

   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.

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

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

   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.

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

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

   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.

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

7. Median Time to Discontinuation From the Index Treatment

   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.

   Measured: 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)

8. Median Time to Switch From the Index Treatment

   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.

   Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted3 Apr 2023
2. Study start10 Mar 2023
3. Primary completion30 Sep 2023
4. Study completion30 Sep 2023

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
• More trials run by PfizerThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.