Purpose of this Study
If you join this study, you will receive shots after your surgery. The shots will contain either a medicine called inclisiran or a placebo, which has no medicine. You will get the first shot after surgery, then another shot at three months, and then every six months after that. You will come to the clinic for each shot. At these visits, the study team will ask about your health, side effects, and any medicines you are taking. You will also have blood tests at certain visits to check how your body is doing.
You have an equal chance of receiving inclisiran or the placebo. The study is planned to last about three years.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older and have a condition called peripheral artery disease, which affects blood flow in the legs. They must have already had, or be planning to have, a procedure to open blocked blood vessels in the legs that was successful.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of this study is to find out if a medicine called inclisiran can help prevent serious problems with the heart and blood vessels. These problems can include heart attacks, strokes, or blockages in the legs that can cause pain or other serious issues. Researchers want to learn if this medicine can help keep blood vessels healthier and lower the risk of these events in the future.
Locations
Duke University Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Evaluation of inclisiran versus placebo for the prevention of major adverse cardiovascular and limb events in patients undergoing percutaneous coronary intervention or peripheral
endovascular intervention (Vascular)
endovascular intervention (Vascular)
Principal Investigator
Elizabeth
Weissler
Protocol Number
PRO00120330
NCT ID
NCT06909565
Phase
IV
Enrollment Status
Pending Open to Enrollment