Comparison of Apixaban Versus Enoxaparin (CARE)

Comparison of Apixaban Versus Enoxaparin as Venous Thromboembolism Prophylaxis After Radical Cystectomy

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Bladder Cancer
• Intervention / Treatment: Other: enoxaparin; Other: apixaban

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: enoxaparin; Participants will be randomized to receive a prescription for prophylactic enoxaparin
Experimental: 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.	Other: apixaban; Participants will be randomized to receive a prescription for prophylactic apixaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	proportion of days covered	Day of discharge to post-operative day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction as measured by 2. National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)	patient satisfaction with their VTE prophylaxis drug	Day of discharge to post-operative day 30
Reasons for non-adherence	patient-reported issues with adherence	Day of discharge to post-operative day 30
VTE rate	rate of venous thromboembolism events	Day of discharge to post-operative day 90
Bleeding rate	rate of major and minor bleeding events	Day of discharge to post-operative day 90
Cost	patient out of pocket cost to fill their VTE prophylaxis prescription	Day of discharge to post operative day 90

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: American Urological Association
• Investigators: Principal Investigator: Katharine F Michel, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2023
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Carbohydrates; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Enoxaparin; apixaban
• Other Study ID Numbers: UPCC 15823

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No