ACCLAIM-Lp(a) EZEF
Brief description of study
The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular (CV) risk in participants with high lipoprotein(a) who have CV disease or are at risk of a heart attack or stroke. The study aims to learn whether lepodisiran can reduce problems like heart attack or stroke, whether it works better than a placebo, and what the possible side effects are.
Detailed description of study
This study is investigating a study drug known as lepodisiran (LY3819469) to see if it can help reduce major CV events.
Throughout the study, study activities may occur at the study doctor’s office, the participant’s home, or other specified locations.
The study is divided into the Screening Period, which can last up to 6 weeks, and the Study Treatment Period, which may last for about 208 weeks. The participants will receive either lepodisiran or a placebo. Neither the participant nor the study team will know which study drug is used. The study drug is taken by an injection under the skin. The participant receives the first 3 doses every 6 months and the remaining doses every 12 months.
There will be a final visit at the end of the study and at least 30 days after the last dose of the study drug.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
-
Age: 99 years or below
-
Gender: All
Inclusion
Have Lipoprotein(a)
Meet criteria of either 2a or 2b
2a: Individuals with established ASCVD with an event or revascularization.
2b: Individuals 55 years of age or older who are at risk for a first CV event and either: Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without history of event or revascularization; known familial hypercholesteremia; or a combination of high-risk factors.
Exclusion
Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, < 90 days before screening.
Have uncontrolled hypertension
Have New York Heart Association class IV heart failure
Have severe renal failure
