Comparison of Apixaban Versus Enoxaparin

Bladder Cancer Clinical Trial

— CARE  

Official title:

Comparison of Apixaban Versus Enoxaparin as Venous Thromboembolism Prophylaxis After Radical Cystectomy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06243510
• Other study ID #: UPCC 15823
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 24, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• apixaban
Participants will be randomized to receive a prescription for prophylactic apixaban
• enoxaparin
Participants will be randomized to receive a prescription for prophylactic enoxaparin

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	American Urological Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	proportion of days covered	Day of discharge to post-operative day 30
Secondary	Cost	patient out of pocket cost to fill their VTE prophylaxis prescription	Day script is filled
Secondary	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	Day of discharge to post-operative day 30
Secondary	Reasons for non-adherence	patient-reported issues with adherence	Day of discharge to post-operative day 30
Secondary	VTE rate	rate of venous thromboembolism events	Day of discharge to post-operative day 90
Secondary	Bleeding rate	rate of major and minor bleeding events	Day of discharge to post-operative day 90