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Trial Title:
Comparison of Apixaban Versus Enoxaparin
NCT ID:
NCT06243510
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Enoxaparin
Apixaban
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
apixaban
Description:
Participants will be randomized to receive a prescription for prophylactic apixaban
Arm group label:
Apixaban
Intervention type:
Other
Intervention name:
enoxaparin
Description:
Participants will be randomized to receive a prescription for prophylactic enoxaparin
Arm group label:
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital of the University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Start date:
November 24, 2023
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Collaborator:
Agency:
American Urological Association
Agency class:
Other
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06243510
