NCT05795062

Treatment Patterns Among Patients With Venous Thromboembolism in the United States

Completed Results posted Last updated 22 November 2024

What this trial tests

trial testing apixaban in Venous Thromboembolism in 13,945 participants. Completed in 30 September 2023.

Timeline

10 March 2023

Primary endpoint
30 September 2023

30 September 2023

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	13,945
Start date	10 March 2023
Primary completion	30 September 2023
Estimated completion	30 September 2023
Sites	1 location across United States

Drugs / interventions tested

• apixaban (apixaban) — full drug profile →
• warfarin (warfarin) — full drug profile →

Conditions studied

• Venous Thromboembolism — all drugs for Venous Thromboembolism →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Venous Thromboembolism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Apixaban	11966
Warfarin	1979

Mean Number of Persistent Days Primary · 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.

Group	Value	95% CI
Apixaban	233.5	± 302.9
Warfarin	242.6	± 304.4

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

Group	Value	95% CI
Apixaban	50.5
Warfarin	52.2

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

Group	Value	95% CI
Apixaban	72.9
Warfarin	75.2

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

Group	Value	95% CI
Apixaban	6.0
Warfarin	20.9

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

Group	Value	95% CI
Apixaban	7.1
Warfarin	24.3

Median Time to Discontinuation From the Index Treatment Primary · 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.

Group	Value	95% CI
Apixaban	5.97	5.83 – 6.07
Warfarin	5.67	5.17 – 6.03

Median Time to Switch From the Index Treatment Primary · 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.

Group	Value	95% CI
Apixaban	NA	NA – NA
Warfarin	NA	NA – NA

Incidence Rate of Recurrent VTE Events Secondary · 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.

Group	Value	95% CI
Apixaban	1.2
Warfarin	2.5

Median Time to Recurrent VTE Secondary · 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.

Group	Value	95% CI
Apixaban	NA	NA – NA
Warfarin	NA	NA – NA

Incidence Rate of Major Bleeding Events Secondary · 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.

Group	Value	95% CI
Apixaban	1.5	1.2 – 1.8
Warfarin	2.0	1.3 – 2.9

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

Group	Value	95% CI
Apixaban	17.7	16.7 – 18.7
Warfarin	21.3	18.8 – 24.1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.