A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients. (NCT05739383) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
United States, Argentina, Australia14,012 participantsStarted 2023-03-09
Plain-language summary
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
Who can participate
Age range
40 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis ≥20% but \<50% in the left main coronary artery or stenosis ≥20% but \<70% in any other major epicardial coronary artery, or
. Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or
. High 10-year ASCVD risk ≥20%, or
. Intermediate 10-year ASCVD risk 7.5% - \<20% with at least 2 risk-enhancing factors.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial studying inclisiran in people who haven't had a heart attack or stroke yet — would I be considered 'high-risk' enough for primary prevention to even be a candidate for a study like this, and how does that compare to just starting standard cholesterol-lowering therapy now?
2The trial is no longer enrolling new patients — does that mean I've missed the window to participate, and are there any similar active trials studying inclisiran or other PCSK9-targeting treatments that I might still be eligible for?
3The main thing this trial is measuring is time to a first major cardiovascular event like heart attack or stroke — given that it's still ongoing and full results aren't in yet, how much do we actually know so far about whether inclisiran prevents these events in people who haven't had one before?
4Inclisiran is given as an injection twice a year rather than a daily pill — how might that dosing schedule affect my life practically, and would it be better or worse for me compared to a daily statin or other lipid-lowering medication?
5Since this is a primary prevention trial focused on people who are at high risk but haven't had a cardiovascular event yet, how would you weigh the potential benefits of joining a study like this against simply optimizing the treatments I'm already on?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to the first occurrence of 4P-MACE
Timeframe: Time to the first occurrence of 4P-MACE (up to approximately 75 months)