← Back to Search

Anticoagulant

Apixaban vs Enoxaparin for Bladder Cancer (CARE Trial)

N/A

Waitlist Available

Led By Katharine F Michel, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Failure to be discharged by post-operative day 14

Failure to undergo radical cystectomy with concurrent urinary diversion and pelvic lymph node dissection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of discharge to post-operative day 90

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to compare the experiences of bladder cancer patients taking blood thinners at home after bladder surgery. It wants to know if patients are equally good at following the instructions for apixaban and en

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, common ones for anticoagulants like enoxaparin and apixaban include bleeding risks, potential bruising or pain at injection sites (for enoxaparin), nausea, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am diagnosed with a specific bladder cancer and plan to have surgery including lymph node removal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I was in the hospital for more than 14 days after surgery.

Select...

I have not had surgery to remove my bladder along with urinary diversion and lymph node removal.

Select...

I cannot take certain blood thinners due to a medical condition.

Select...

I have not been prescribed enoxaparin or apixaban.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of discharge to post-operative day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of discharge to post-operative day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of discharge to post-operative day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence

Secondary study objectives

Bleeding rate

Cost

Reasons for non-adherence

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 5Eligibility criteria met