Recruiting patients (≥40 but <80 years of age) at high cardiovascular risk, to participate in a clinical trial. Must be at an increased risk for a first
MACE – Major Adverse Cardiovascular Event (i.e. no prior major ASCVD – Atherosclerotic Cardiovascular Disease event), defined as any one of
a. evidence of atherosclerotic CAD – Coronary Artery Disease on CT – Computer Tomography or invasive coronary angiogram
b. coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units
c. high 10-year ASCVD – Atherosclerotic Cardiovascular Disease risk ≥20%
d. intermediate 10-year ASCVD risk 7.5% – <20% with at least 2 risk- enhancing factors (to be reviewed during screening)
Individuals must maintain a stable dose (if on a background LLT – Lipid-Lowering Therapy) for at least 4 weeks prior to the screening visit, and
be willing to remain on this background therapy for the duration of the study. LDL-C – Low Density Lipoprotein Cholesterol ≥70 mg/dL (≥1.81
mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit, is also required.
Participants will receive investigational treatment (active study drug) or placebo, via subcutaneous injection. Study treatment and study-related
assessments will be provided. Reimbursement for study-related expenses may be provided.
Study participation will last about 3-5 years and involve about 16 visits to the study centre, plus a safety follow-up call.
The following information is from ClinicalTrials.gov
Last Update Posted: September 24, 2023
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.
Condition or Disease:
Primary Prevention of Atherosclerotic Cardiovascular Disease
Intervention/Treatment:Drug: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Ages Eligible for Study:
40 Years and 79 Years (Adult)
Sexes Eligible for Study:
At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:
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 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. If on a background lipid lowering therapy, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study. LDL-C ≥70 mg/dL (≥1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit. Exclusion Criteria: History of major ASCVD event. History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization Active liver disease or hepatic dysfunction Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab) Pregnant or nursing (lactating) women Women of childbearing potential unless they are using effective methods of contraception while taking study treatment Other protocol-defined inclusion/exclusion criteria may apply.
Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.