Bladder Cancer Clinical Trial

Comparison of Apixaban Versus Enoxaparin

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study is for people with:

Bladder Cancer

Estimated Enrollment:

90

Study ID:

NCT06243510

Recruitment Status:

Enrolling by invitation

Sponsor:

Abramson Cancer Center at Penn Medicine

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There is 1 Location for this study

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

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

90

Study ID:

NCT06243510

Recruitment Status:

Enrolling by invitation

Sponsor:


Abramson Cancer Center at Penn Medicine

How clear is this clinincal trial information?

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