Study Details
Testing the Drug Inclisiran for Adults with Atherosclerotic Cardiovascular Disease
(IRB#: IRB_00177770)
This study will test an approved study drug, Inclisiran, to treat people with heart disease to see if it lowers bad cholesterol. The study wants to see if the drug will help people with the disease. People in the study will be randomly chosen to be treated with Inclisiran for the first 12 months (Part 1) of the study. If people in the study did not receive Inclisiran during Part 1 of the study, they will continue participation for another 12 months (Part 2) and receive Inclisiran in the second 12 months. Being in the study requires attending 4 or 7 in-person visits at the study clinic, which lasts 12 or 24 months, depending on the assigned group. Medical tests will be done to track the health of participants.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 18 years and older
- Diagnosis or documented risk of Atherosclerotic Cardiovascular Disease
- Required to be on statin (medication used to lower cholesterol) therapy or documented intolerance (unable to use statin)
- Attend in-person visits at the study clinic
Exclusion Criteria
- Treatment with Inclisiran within 180 days before participation
- Serious hepatic (liver) impairment, including active liver infections, metabolic diseases, or neoplasms
- End-stage renal disease
- Planned use of other study products or devices during the study
- Pregnant or breastfeeding
Will I be paid for my time?
Yes
IRB#: IRB_00177770
PI: Tanya Wilcox
Department: DIV OF CARDIOVASCULAR MEDICINE
Approval Date: 2025-01-16 07:00:00
Study Categories: Heart Studies
Specialties: Cardiology
I am Interested