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OpenTrials
Completed

NCT Number: NCT06243510

Comparison of Apixaban Versus Enoxaparin

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Apixaban

Other

Participants will be randomized to receive a prescription for prophylactic apixaban

enoxaparin

Other

Participants will be randomized to receive a prescription for prophylactic enoxaparin

Primary outcomes

  1. Adherence

    Time frame: Day of discharge to post-operative day 30

    proportion of days covered

Secondary outcomes

  1. Cost

    Time frame: Day of discharge to post operative day 90

    patient out of pocket cost to fill their VTE prophylaxis prescription

  2. 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

    patient satisfaction with their VTE prophylaxis drug

  3. Reasons for non-adherence

    Time frame: Day of discharge to post-operative day 30

    patient-reported issues with adherence

  4. VTE rate

    Time frame: Day of discharge to post-operative day 90

    rate of venous thromboembolism events

  5. Bleeding rate

    Time frame: Day of discharge to post-operative day 90

    rate of major and minor bleeding events

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • American Urological Association

Registry information

Official study title

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

Acronym: CARE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2024
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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