ACCLAIM-CTA
The ACCLAIM-CTA study investigates how the medication lepodisiran affects the amount and type of plaque in the coronary blood vessels of adults who have high lipoprotein (a) (Lp(a)) levels.
About This Study
Summary
Like other low-density lipoproteins (LDLs), lipoprotein (a) (Lp(a)) carries cholesterol and other materials in your blood. High levels of Lp(a) promote abnormal inflammation and blood clotting. In addition, Lp(a) can deposit materials on the inner surfaces of blood vessels to form plaques. These plaques contain fat, cholesterol, calcium, and various proteins and can block blood flow to organs including the heart, brain, kidneys, and lungs. This increases the risk for stroke, heart attack, stiffening (calcification) and narrowing (stenosis) of the aortic valve in the heart, stenosis of peripheral and coronary arteries, and other problems. A person’s Lp(a) level is primarily inherited (determined by genetics) remains fairly constant from childhood onward. Unfortunately, exercise, lifestyle, and dietary habits have little effect on reducing Lp(a) levels.
To potentially identify a treatment to decrease the risk of cardiovascular (CV) and other health consequences of high Lp(a) levels, ACCLAIM-CTA asks whether the investigational drug lepodisiran affects the amount and type of plaque in the heart’s vessels. During the study, Carilion researchers use coronary computed tomography (CT) angiography (CCTA; a noninvasive imaging technique) to follow changes in plaque size and vessel diameter. Participants who are approved to join ACCLAIM-CTA are assigned randomly (50:50, like a coin toss) to receive either lepodisiran (under the skin) or shots that look identical but do not contain any medication (placebo). Neither the lead scientist nor participants can choose or know what group they're assigned to. Throughout the study, members of the research team check in with participants for health assessments and follow-up activities. Participants can expect to be involved in ACCLAIM-CTA for about 120 weeks.
To be included in ACCLAIM-CTA, participants must be / have
- Adult (45 to 80 years old)
- Lp(a) ≥175 nmol/L
- Currently have CV disease or are at risk for a first CV event
- Have evidence of coronary artery disease on screening CCTA
- Dosages of lipid-lowering medications (if prescribed) should be stable for at least 8 weeks
To be included in ACCLAIM-CTA, participants must not be / have
- Major CV event fewer than 60 days before measurement of the Lp(a) level used for eligibility
- Uncontrolled high blood pressure at screening
- Moderate to severe renal dysfunction
- Severe heart failure
- History of coronary artery bypass graft surgery (CABG) or planned coronary angiography, percutaneous coronary intervention (PCI), CABG, or valvular intervention
Keywords
Atherosclerosis; Cardiovascular disease; Dyslipidemia; EZEJ; Heart attack; Lipoprotein (a); Lp(a); Stroke
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Dr. Wahid is an experienced clinical trialist and hospital medicine specialist. She particularly focuses on understanding factors that influence healthcare outcomes in various subpopulations, such as hospitalized patients and older adults. Several of her studies address the management of sepsis, thrombosis prevention, and the long-term health of COVID-19 patients.
Official title of study
A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Lepodisiran to Investigate the Effect on Coronary Plaque in Adults with Elevated Lp(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event (ACCLAIM-CTA)
Funding mechanism
Industry sponsored by Eli Lilly