Comparison of Apixaban Versus Enoxaparin

Not Applicable

• Conditions: Bladder Cancer
• Interventions: Other: enoxaparin; Other: apixaban

• Registration Number: NCT06243510
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-24
• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Able to communicate in English over the phone
4. Male or female, age >18 years
5. 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxaparin	enoxaparin	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.
Apixaban	apixaban	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.

Primary Outcome Measures

Name	Time	Method
Adherence	Day of discharge to post-operative day 30	proportion of days covered

Secondary Outcome Measures

Name	Time	Method
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	patient satisfaction with their VTE prophylaxis drug
VTE rate	Day of discharge to post-operative day 90	rate of venous thromboembolism events
Cost	Day of discharge to post operative day 90	patient out of pocket cost to fill their VTE prophylaxis prescription
Reasons for non-adherence	Day of discharge to post-operative day 30	patient-reported issues with adherence
Bleeding rate	Day of discharge to post-operative day 90	rate of major and minor bleeding events

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States