Comparison of Apixaban Versus Enoxaparin (NCT06243510) | Clinical Trial Compass
By InvitationNot Applicable
Comparison of Apixaban Versus Enoxaparin
United States90 participantsStarted 2023-11-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Adherence
Timeframe: Day of discharge to post-operative day 30