Comparison of Apixaban Versus Enoxaparin

NCT ID: NCT06243510

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-24
• Study Completion Date: 2026-06-30

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

enoxaparin

Intervention Type: OTHER

Participants will be randomized to receive a prescription for prophylactic enoxaparin

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.

Group Type: EXPERIMENTAL

apixaban

Intervention Type: OTHER

Participants will be randomized to receive a prescription for prophylactic apixaban

Interventions

apixaban

Participants will be randomized to receive a prescription for prophylactic apixaban

Intervention Type: OTHER

enoxaparin

Participants will be randomized to receive a prescription for prophylactic enoxaparin

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Urological Association

OTHER

Sponsor Role: collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Katharine Michel

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katharine F Michel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UPCC 15823

Identifier Type: -

Identifier Source: org_study_id