90 Participants Needed

Apixaban vs Enoxaparin for Bladder Cancer

(CARE Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Abramson Cancer Center at Penn Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those already on a therapeutic dose of anticoagulants. If you're taking antiplatelet agents, you may still be eligible to participate.

Is Apixaban safe for use in humans?

Research shows that Apixaban, used for preventing blood clots after bladder cancer surgery, did not cause major bleeding or symptomatic blood clots in patients. It is considered safe and may improve patient satisfaction compared to injectable alternatives like Enoxaparin.12345

How does the drug Apixaban differ from Enoxaparin for bladder cancer treatment?

Apixaban is an oral medication, which makes it easier for patients to take compared to Enoxaparin, which is an injectable drug. This oral administration can improve patient adherence and satisfaction, especially after bladder cancer surgery, by potentially extending the duration of blood clot prevention without the need for injections.12356

What data supports the effectiveness of the drug Apixaban for preventing blood clots after bladder cancer surgery?

Research shows that Apixaban, an oral medication, is effective and safe for preventing blood clots after bladder cancer surgery, with no major bleeding events or symptomatic blood clots reported in patients. This suggests it could be a good alternative to injectable medications like Enoxaparin, potentially improving patient adherence and satisfaction.12347

Who Is on the Research Team?

KF

Katharine F Michel, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for bladder cancer patients who've had surgery to remove their bladder. They must be able to self-administer anticoagulation medication at home and participate in phone surveys. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am over 18 years old.
Provision of signed and dated informed consent form
I can speak and understand English over the phone.
See 2 more

Exclusion Criteria

I was in the hospital for more than 14 days after surgery.
I am taking blood thinners before surgery, but not antiplatelet drugs.
I have not had surgery to remove my bladder along with urinary diversion and lymph node removal.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a prescription for either enoxaparin or apixaban and self-administer at home until post-operative day 30

4 weeks
Self-administered at home

Follow-up

Participants are monitored for safety and effectiveness after treatment, with phone calls at days 30 and 90 to assess trial outcomes

8 weeks
2 phone calls

What Are the Treatments Tested in This Trial?

Interventions

  • Apixaban
  • Enoxaparin
Trial Overview The study compares two blood thinners, enoxaparin and apixaban, for use after bladder removal surgery. Patients will randomly receive one of the drugs to take until day 30 post-surgery, with follow-up calls on days 30 and 90 to assess adherence, preference, and cost.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: ApixabanExperimental Treatment1 Intervention
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.
Group II: EnoxaparinActive Control1 Intervention
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.

Apixaban is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Eliquis for:
  • Deep vein thrombosis
  • Pulmonary embolism
  • Nonvalvular atrial fibrillation
🇺🇸
Approved in United States as Eliquis for:
  • Deep vein thrombosis
  • Pulmonary embolism
  • Nonvalvular atrial fibrillation
  • Stroke prevention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials
425
Recruited
464,000+

American Urological Association

Collaborator

Trials
5
Recruited
640+

Published Research Related to This Trial

In a study of 374 patients who underwent robot-assisted radical cystectomy, both oral apixaban and injectable enoxaparin were found to be equally effective in preventing venous thromboembolism (VTE), with VTE rates of 1.6% for apixaban and 3.2% for enoxaparin, showing no statistically significant difference (P = 0.5).
Apixaban was demonstrated to be a safe option for VTE prophylaxis after surgery, with no significant differences in major bleeding, complications, readmission, or mortality rates compared to enoxaparin.
Outcomes from a prospectively implemented protocol using apixaban after robot-assisted radical cystectomy.Rich, JM., Elkun, Y., Geduldig, J., et al.[2023]
Apixaban is an effective oral medication for preventing venous thromboembolism (VTE) after knee or hip replacement surgery, showing better efficacy than subcutaneous enoxaparin sodium in phase III trials ADVANCE-2 and -3 without significantly increasing bleeding risk.
While apixaban did not meet noninferiority criteria compared to a specific enoxaparin regimen in the ADVANCE-1 trial, it was associated with fewer bleeding complications, suggesting it may be a safer option for thromboprophylaxis.
Apixaban: a review of its use in the prevention of venous thromboembolism after knee or hip replacement surgery.Deeks, ED.[2021]

Citations

Outcomes from a prospectively implemented protocol using apixaban after robot-assisted radical cystectomy. [2023]
Apixaban vs Enoxaparin for Post-Surgical Extended-Duration Venous Thromboembolic Event Prophylaxis: A Prospective Quality Improvement Study. [2023]
Initial Experience with Apixaban for Extended Venous Thromboembolism Prophylaxis After Radical Cystectomy. [2022]
Comparison of apixaban to rivaroxaban and enoxaparin in acute cancer-associated venous thromboembolism. [2020]
Apixaban for extended postoperative thromboprophylaxis in gynecologic oncology patients undergoing laparotomy. [2023]
Cost-effectiveness of apixaban for prevention of venous thromboembolic events in patients after gynecologic cancer surgery. [2021]
Apixaban: a review of its use in the prevention of venous thromboembolism after knee or hip replacement surgery. [2021]
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