V-INTERVENTION with inclisiran vs placebo for peripheral endovascular intervention

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)

Principal Investigator

Elizabeth
Weissler

Protocol Number

PRO00120330

NCT ID

NCT06909565

Phase

IV

Enrollment Status

Pending Open to Enrollment