NCT06243510

Brief Summary

The goal of this randomized trial is to compare bladder cancer patient experiences taking prophylactic anticoagulation at home after surgery to remove their bladder. The main questions it aims to answer are:

  • Are patients equally adherent to apixaban as they are enoxaparin? Why or why not?
  • Do patients prefer apixaban or enoxaparin?
  • What is the typical patient cost to take apixaban vs enoxaparin after surgery? Participants will be randomized to receive a prescription for either enoxaparin or apixaban which they will then fill themselves and self-administer at home until post-operative day 30. They will receive phone calls from study coordinators at days 30 and 90 to complete questionaries over the phone to assess trial outcomes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Nov 2023Jun 2026

Study Start

First participant enrolled

November 24, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

January 23, 2024

Last Update Submit

January 27, 2026

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Adherence

    proportion of days covered

    Day of discharge to post-operative day 30

Secondary Outcomes (5)

  • Cost

    Day of discharge to post operative day 90

  • Satisfaction as measured by 2. National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)

    Day of discharge to post-operative day 30

  • Reasons for non-adherence

    Day of discharge to post-operative day 30

  • VTE rate

    Day of discharge to post-operative day 90

  • Bleeding rate

    Day of discharge to post-operative day 90

Study Arms (2)

Enoxaparin

ACTIVE COMPARATOR

Participants randomized to receive script for prophylactic dose of enoxaparin. Dosing will be done based on clinical providers (pharmacists) according to usual care. Participants will fill the script themselves.

Other: enoxaparin

Apixaban

EXPERIMENTAL

Participants randomized to receive script for prophylactic dose of apixaban. Dosing will be done based on clinical providers (pharmacists) according to usual care. Participants will fill the script themselves.

Other: apixaban

Interventions

apixabanOTHER

Participants will be randomized to receive a prescription for prophylactic apixaban

Apixaban
enoxaparinOTHER

Participants will be randomized to receive a prescription for prophylactic enoxaparin

Enoxaparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Able to communicate in English over the phone
  • Male or female, age \>18 years
  • Diagnosed with biopsy-proven, urothelial cell carcinoma (any T stage, N0-1, M0) with plan for radical cystectomy with urinary diversion and concurrent pelvic lymph node dissection as treatment

You may not qualify if:

  • Preoperative use of a therapeutic dose of anticoagulant (this notably does not exclude patients taking antiplatelet agents)
  • Failure to undergo radical cystectomy with concurrent urinary diversion and pelvic lymph node dissection
  • Failure to be discharged by post-operative day 14
  • Failure to receive a script for enoxaparin or apixaban.
  • Any medical condition which precludes treatment with either enoxaparin or apixaban (including dialysis, hemophilia or any other bleeding diathesis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

apixabanEnoxaparin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Katharine F Michel, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 6, 2024

Study Start

November 24, 2023

Primary Completion

March 15, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)