Comparison of Apixaban Versus Enoxaparin

Launched by ABRAMSON CANCER CENTER AT PENN MEDICINE · Feb 2, 2024

Keywords

ClinConnect Summary

This study is a randomized trial that compares two medicines given after bladder cancer surgery to prevent blood clots: apixaban (a pill you take at home) versus enoxaparin (a shot you give yourself at home). Participants are randomly assigned to one of these options and will self-administer the medicine from discharge after surgery until day 30. The main thing researchers want to learn is how well patients stick to the plan (adherence) and why, but they also want to know which drug patients prefer and how much it costs the patient to use each option. The trial will also look at clotting events, bleeding, and overall satisfaction with the treatment.

Who can join: adults 18 or older with biopsy-proven bladder cancer who are planned to have radical cystectomy with urinary diversion and pelvic lymph node dissection. Key criteria include being willing and able to consent, English-speaking by phone, and not already on a therapeutic dose of anticoagulants before surgery. People who haven’t been discharged by day 14 after surgery or who don’t get a prescription for either drug aren’t eligible. Participants will be followed by phone interviews around day 30 and day 90 to answer questions about adherence, satisfaction, and any problems. The study is happening at the Hospital of the University of Pennsylvania, is designed as a parallel group trial with about 90 participants, and enrollment is ongoing by invitation. Results are not yet available.

Gender

ALL

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)