Clinical trial NCT06243510: Comparison of Apixaban Versus Enoxaparin
Official title: Comparison of Apixaban Versus Enoxaparin as Venous Thromboembolism Prophylaxis After Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: American Urological Association
First posted: 2024-02-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Adherence
timeFrame: Day of discharge to post-operative day 30
Secondary outcomes:
measure: Cost
timeFrame: Day of discharge to post operative day 90
measure: Satisfaction as measured by 2. National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)
timeFrame: Day of discharge to post-operative day 30
measure: Reasons for non-adherence
timeFrame: Day of discharge to post-operative day 30
measure: VTE rate
timeFrame: Day of discharge to post-operative day 90
measure: Bleeding rate
timeFrame: Day of discharge to post-operative day 90
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katharine F Michel, MD
role: PRINCIPAL_INVESTIGATOR
References: