This phase IV trial compares the patient experience of taking apixaban or enoxaparin for the prevention of venous thromboembolism (VTE) after undergoing surgery to remove all of the bladder as well as nearby tissue and organs (radical cystectomy). VTE is the migration of a blood clot formed within a vein to a site distant from the formation. Radical cystectomy is a major operation with several associated risks, one of which is an increased risk of blood clots during the recovery period after surgery. Developing a blood clot, if not fatal, can lead to many months of taking high dose blood thinners, which have associated risks of their own including excessive bleeding, the need for follow-up visits, and high costs of the medications. To lower the chances of forming a blood clot following a radical cystectomy, patients can be sent home to take a low dose of blood thinner until the 30th day after surgery. Apixaban and enoxaparin are commonly used blood thinners to help prevent blood clots from forming in patients undergoing radical cystectomy. Despite the benefits of apixaban and enoxaparin, patients may not like to take them due to reasons such as, the need to self-administer by a shot, cost, and frequent dosing. Taking apixaban may be more acceptable to patients than enoxaparin for the prevention of VTE after radical cystectomy.
Additional locations may be listed on ClinicalTrials.gov for NCT06243510.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Active
Contact: Katharine Michel
Phone: 215-615-3780
PRIMARY OBJECTIVE:
I. To compare rates of adherence to discharge on enoxaparin versus (vs) apixaban.
SECONDARY OBJECTIVES:
I. To explore possible reasons for adherence vs non adherence.
II. To compare the cost of enoxaparin vs apixaban.
TERTIARY OBJECTIVE:
I. To collect efficacy and safety data regarding both forms of prophylaxis.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care radical cystectomy and receive a prescription for enoxaparin on study. Patients are instructed to take enoxaparin subcutaneously (SC) once daily (QD) from the day after discharge through post operative day (POD) 30 in the absence of unacceptable toxicity. Patients that have or develop a contraindication to enoxaparin prior to discharge are considered for crossover and can be switched to the apixaban arm, if the patient does not have a contraindication to apixaban.
ARM II: Patients undergo standard of care radical cystectomy and receive a prescription for apixaban on study. Patients are instructed to take apixaban orally (PO) twice daily (BID) from the day after discharge through POD 30 in the absence of unacceptable toxicity. Patients that have or develop a contraindication to apixaban prior to discharge are considered for crossover and can switch to the enoxaparin arm, if the patient does not have a contraindication to enoxaparin.
After completion of study treatment, patients are followed up at POD 30 and POD 90.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorKatharine Michel
