Apixaban vs Enoxaparin for Bladder Cancer

(CARE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Must not be taking: Anticoagulants

Disqualifiers: Dialysis, Hemophilia, Bleeding diathesis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how bladder cancer patients feel about taking either apixaban or enoxaparin at home after bladder removal. It will compare medication adherence, patient preference, and associated costs. Patients with bladder cancer planning bladder removal surgery, who have not used blood thinners before, might be suitable candidates. Participants will receive one of the two medications and share their experiences through phone surveys. As an unphased trial, this study provides patients the chance to contribute to valuable research that could enhance post-surgery care for future patients.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that apixaban is safe to use after bladder cancer surgery. It effectively prevents blood clots without causing major bleeding. Patients using apixaban have a lower risk of blood clots and serious bleeding compared to those using other treatments like low-molecular-weight heparin, another type of blood thinner.

Specifically, patients who took apixaban for 28 days after bladder surgery experienced no major complications, indicating it is well-tolerated during recovery.

Enoxaparin, the other treatment in this trial, is also a well-known blood thinner. It is commonly used and generally considered safe for preventing blood clots after surgeries. Both treatments have a strong safety record, making them reliable options for patients recovering from bladder cancer surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Apixaban and Enoxaparin for bladder cancer because these treatments offer new ways to manage blood clot risks, which are common in cancer patients. Unlike traditional chemotherapy and surgery, which primarily target tumors, Apixaban and Enoxaparin focus on blood-thinning to prevent clots. Apixaban, an oral anticoagulant, is particularly intriguing due to its ease of administration compared to injectable options like Enoxaparin. This convenience could potentially improve patient quality of life and adherence to treatment, making these options promising additions to bladder cancer care.

What evidence suggests that this trial's treatments could be effective for bladder cancer patients?

This trial will compare Apixaban and Enoxaparin for their effectiveness in preventing blood clots in bladder cancer patients. Studies have shown that Apixaban reduces the risk of blood clots in cancer patients. Specifically, research indicates that patients taking Apixaban after bladder cancer surgery did not experience major bleeding or noticeable blood clots. Other studies found that Apixaban lowered the rate of dangerous blood clots, known as venous thromboembolism (VTE), compared to a placebo. Enoxaparin, which participants in this trial may also receive, is another well-known treatment that helps prevent blood clots, especially after surgery. Both Apixaban and Enoxaparin are anticoagulants, meaning they help prevent blood clots, and both have been used safely in cancer patients. ^{2 4 6 7 8}

Who Is on the Research Team?

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.

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.

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?

Group I: Apixaban Experimental Treatment 1 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: Enoxaparin Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban: a review of its use in the prevention of venous thromboembolism after knee or hip replacement surgery. Deeks, ED.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7895542/

Effectiveness and Safety of Apixaban, Low-Molecular-Weight ... Patients with VTE and active cancer who initiated apixaban had a lower risk of recurrent VTE and MB compared with LMWH patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3840507/

Effect of anticoagulants and antiplatelet agents on the efficacy ... We performed a systematic review of publications describing a correlation between oral anticoagulant medications and intravesical BCG outcome.

3. withpower.com withpower.com/trial/phase-bladder-cancer-cancer-10-2023-94c32

Apixaban vs Enoxaparin for Bladder Cancer (CARE Trial) Research shows that Apixaban, used for preventing blood clots after bladder cancer surgery, did not cause major bleeding or symptomatic blood clots in patients.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S004938482030582X

Safety and efficacy of apixaban thromboprophylaxis in ... In patients with and without metastatic disease, apixaban thromboprophylaxis was associated with a significantly lower rate of VTE compared to placebo.

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/10/NCT06243510/Prot_SAP_000.pdf

Protocol 854199 Patients who have undergone radical cystectomy for bladder cancer will be randomized to receive a prescription for either enoxaparin or apixaban ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10091894/

The impact of antithrombotic therapy on the time of detection ... The aim of this article was to investigate the impact of chronic antithrombotic therapy (AT) use on the time of detection of bladder cancer.

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa1814468

Apixaban to Prevent Venous Thromboembolism in Patients ... Apixaban therapy resulted in a significantly lower rate of venous thromboembolism than did placebo among intermediate-to-high-risk ambulatory patients with ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2019.37.7_suppl.488

Twenty-eight-day prophylaxis with apixaban after radical ... The objective of this study was to identify safety concerns with using this prophylaxis for an extended time after radical cystectomy for bladder cancer.