Purpose of this Study
This study has two parts. The first part is called the Screening Period and lasts about 12 weeks. During this time, people will visit the doctor 5 to 7 times. They will have tests like checking their genes, memory tests, brain scans, a spinal tap, and other exams like blood tests and skin checks.
The second part is called the Study Dosing Period. In this part, people will be randomly chosen to take either a study medicine or a fake pill that looks the same. They will take one pill every day for 5 to 8 years. During this time, they will go to the doctor every few months to answer questions, get exams, and have more tests like brain scans and lab work.
Who Can Participate?
Eligibility
This study is for adults who are 40 years old or older. They must have had heart problems before, like a heart attack or needing a stent. They also need to feel worried, stressed, or nervous. People in the study should not already be taking medicine to help their mood, and they should not be part of an exercise program right now.
Age Range
40-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No
What is Involved?
Description
This study is being done to learn how exercise and medicine can help adults with heart problems feel less worried and stressed. It is important because feeling worried and stressed can make heart problems worse.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) versus Treatment of Investigator’s Choice (IC) in Patients with Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy
Principal Investigator
Angeles
Secord
Protocol Number
PRO00119042
NCT ID
NCT07166094
Phase
III
Enrollment Status
Pending Open to Enrollment