Apixaban vs Enoxaparin for Bladder Cancer
(CARE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byKatharine F Michel, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abramson Cancer Center at Penn Medicine

No Placebo Group

Trial Summary

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.

Research Team

Katharine F Michel, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

Treatment Details

Interventions

Apixaban (Anticoagulant)
Enoxaparin (Anticoagulant)

Trial OverviewThe 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.

Participant Groups

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.