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Anticoagulant
Apixaban 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of discharge to post-operative day 90
Awards & highlights
CARE Trial 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.Check my eligibility
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.See study design
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.
CARE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am diagnosed with a specific bladder cancer and plan to have surgery including lymph node removal.
CARE Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence
Secondary outcome measures
Bleeding rate
Cost
Reasons for non-adherence
+2 moreCARE 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.
Find a Location
Who is running the clinical trial?
American Urological AssociationOTHER
4 Previous Clinical Trials
545 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,554 Total Patients Enrolled
Katharine F Michel, MDPrincipal InvestigatorUniversity of Pennsylvania
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment process open for this medical study at present?
"As per clinicaltrials.gov, this particular research endeavor is currently not seeking new participants. The trial was initially shared on November 24th, 2023, with the most recent update made on February 2nd, 2024. Despite its inactive status, there are numerous other trials available for enrollment – a total of 368 to be precise."
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