Bladder CancerCARENCT06243510
Comparison of Apixaban Versus Enoxaparin
A study testing apixaban and enoxaparin in people with Bladder Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- apixaban and enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2023to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- Any medical condition which precludes treatment with either enoxaparin or apixaban (including dialysis, hemophilia or any other bleeding diathesis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Comparison of Apixaban Versus Enoxaparin as Venous Thromboembolism Prophylaxis After Radical Cystectomy
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.
- Conditions
- Bladder Cancer
- Being tested
- apixaban, enoxaparin
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apixabanOther
Participants will be randomized to receive a prescription for prophylactic apixaban
enoxaparinOther
Participants will be randomized to receive a prescription for prophylactic enoxaparin
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin | Active comparator | Participants randomized to receive script for prophylactic dose of enoxaparin. Dosing will be done based on clinical providers (pharmacists) according to usual care. Participants will fill the script themselves. Receives: Other: enoxaparin |
| Apixaban | Experimental | Participants randomized to receive script for prophylactic dose of apixaban. Dosing will be done based on clinical providers (pharmacists) according to usual care. Participants will fill the script themselves. Receives: Other: apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
proportion of days covered
Measured: Day of discharge to post-operative day 30
Secondary outcomes (5)
Cost
patient out of pocket cost to fill their VTE prophylaxis prescription
Measured: Day of discharge to post operative day 90
Satisfaction as measured by 2. National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)
patient satisfaction with their VTE prophylaxis drug
Measured: Day of discharge to post-operative day 30
Reasons for non-adherence
patient-reported issues with adherence
Measured: Day of discharge to post-operative day 30
VTE rate
rate of venous thromboembolism events
Measured: Day of discharge to post-operative day 90
Bleeding rate
rate of major and minor bleeding events
Measured: Day of discharge to post-operative day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start24 Nov 2023
- Primary completion30 Jan 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Urological Association
- Responsible party
- Principal investigator, Katharine Michel, Abramson Cancer Center at Penn Medicine
- Investigators
- Katharine F Michel, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243510
- Sponsor's protocol ID
- UPCC 15823
- Acronym
- CARE
- Status last verified
- Jun 2026
- First submitted
- 23 Jan 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Apixaban Versus Enoxaparin as Venous Thromboembolism Prophylaxis After Radical Cystectomy
- ClinicalTrials.gov ID
- NCT06243510
- Acronym / sponsor ID
- CARE / UPCC 15823
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- American Urological Association
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin | Active comparator | Other: enoxaparinParticipants randomized to receive script for prophylactic dose of enoxaparin. Dosing will be done based on clinical providers (pharmacists) according to usual care. Participants will fill the script themselves. |
| Apixaban | Experimental | Other: apixabanParticipants randomized to receive script for prophylactic dose of apixaban. Dosing will be done based on clinical providers (pharmacists) according to usual care. Participants will fill the script themselves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
- Any medical condition which precludes treatment with either enoxaparin or apixaban (including dialysis, hemophilia or any other bleeding diathesis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apixabanParticipants will be randomized to receive a prescription for prophylactic apixaban | Other | Apixaban |
| enoxaparinParticipants will be randomized to receive a prescription for prophylactic enoxaparin | Other | Enoxaparin |
Primary outcome
Adherence
Time frame: Day of discharge to post-operative day 30
proportion of days covered
5 secondary outcomes
Cost
Time frame: Day of discharge to post operative day 90
Satisfaction as measured by 2. National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)
Time frame: Day of discharge to post-operative day 30
Reasons for non-adherence
Time frame: Day of discharge to post-operative day 30
VTE rate
Time frame: Day of discharge to post-operative day 90
Bleeding rate
Time frame: Day of discharge to post-operative day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharine F Michel, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing apixaban and enoxaparin in people with Bladder Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: Day of discharge to post-operative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.