Purpose:
The ACCLAIM-Lp(a) trial is a Phase III, randomized, double-blind, placebo-controlled study to investigate the effect of lepodisiran on the reduction of major adverse cardiovascular events in adults with elevated lipoprotein(a) who have established atherosclerotic coronary-vascular disease (ASCVD) or are at high risk for a first cardiovascular event.
Lipoprotein (a), otherwise known as the” horrible” or “sticky” cholesterol, increases the risk of complications from ASCVD, including heart attack, stroke, peripheral artery disease, and death. Elevated levels of lipoprotein (a), abbreviated as Lp(a), are observed in up to 20% of the population in the United States, with an even higher incidence among African Americans. It is also an inherited as an autosomal dominant disorder, meaning that 50% of family members may also be affected and may need to be screened with a simple blood test. Current guidelines recommend that everyone should be screened at one time using a simple blood test for elevations of Lp(a).
Unfortunately, no medical treatment directed to lower Lp(a) levels is commercially available, as they are being evaluated in clinical trials such as those available at the National Heart Institute. In earlier Phase II clinical trials, lepodisiran was found to lower Lp(a) levels by over 90% and was found to be safe and well tolerated. The purpose of this trial is to investigate the reduction of major adverse cardiovascular events such as heart attack, stroke, and death from cardiovascular causes with lepodisiran treatment compared to placebo in patients who have cardiovascular disease or are at higher risk for developing ASCVD in patients who are already taking cholesterol-lowering therapy such as statins and will continue to do so throughout the trial duration.
Description:
The ACCLAIM- Lp(a) trial is evaluating the ability of a treatment, lepodisiran, in patients who have suffered from a cardiovascular event such as heart attack or stroke or those people who have identified blockages in the coronary, carotid, or peripheral arteries to the legs and also in patients who have multiple risk factors for developing ASCVD.
Participants will be randomly assigned in a 1:1 ratio to receive either lepodisiran or a placebo, added to their existing standard-of-care background medications that should include maximally tolerated doses of statins, the most commonly prescribed cholesterol treatment. This trial is a randomized, double-blind, placebo-controlled study to investigate the reduction of major adverse cardiovascular events such as heart attack, stroke, and death from cardiovascular causes with lepodisiran treatment compared to placebo in adult participants with established ASCVD or high cardiovascular risk because of multiple risk factors. Lepodisiran is administered as an easy-to-administer subcutaneous injection every six months. The average treatment duration will be approximately four years.
Key Eligibility Requirements:
(Please note: Additional eligibility requirements may be assessed at the time of study screening evaluation.)
- Age 18 years and older
- Have an Lp(a) level ≥ 175 nmol/l or 60 mg/dl
- Have a history of heart attack or stroke OR
- Have a history of surgical bypass or stent procedure in a coronary, carotid, or peripheral artery (legs) OR
- Have arterial blockages identified on an ultrasound or angiogram of 50% or over OR
- Have multiple coronary risk factors, including:
o Age ≥ 65 years for men or 70 for women
o History of hypertension, diabetes, tobacco use, chronic kidney disease, family history of coronary-vascular disease, or a coronary calcium score ≥300 - Must be compliant with all medications, including study medications and study visits
Subjects will be excluded who have a history of cancer within the past five years except for skin and localized cervical and prostate cancer, active infection, or major disease that is not currently stable, have issues with substance abuse, or are pregnant.
PARTICIPATION IN THIS TRIAL CAN BE UP TO THREE YEARS
The information we are providing includes important background on a variety of important cardiovascular conditions and ongoing clinical trials. We encourage you to use this information in discussions with your health care professional. Since enrollment in clinical trials are limited in time, we can’t guarantee their availability at any given time. However, we have continued access to new clinical trial opportunities and will share them as soon as they are available.