Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Atherosclerotic Cardiovascular Disease

In brief

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

Key facts

Study ID

NCT05030428

Run by

Novartis Pharmaceuticals

People needed

17004

Starts

2021-11-23

Expected to finish

2027-10-13

Last updated by the study team

2026-07-20

Who can join

Age: 40 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fasting LDL-C ≥ 70 mg/dL at randomization visit
• Stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin greater than or equal to 40 mg QD or rosuvastatin greater than or equal to 20 mg QD
• Established CV disease defined as ANY of the following three conditions
• Spontaneous Myocardial infarction ≥ 4 weeks from screening visit
• History of ischemic stroke occurred ≥ 4 weeks prior to the Screening visit
• Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent claudication with ankle brachial index (ABI) < 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease.

You may not qualify if…

• Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 4 weeks before screening visit
• Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit
• Planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months after the first study visit
• Heart failure NYHA class III or IV
• Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver
• Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years
• Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years
• History of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit
• Pregnant or nursing (lactating) women
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• University of Calif Irvine Med Cntr — Irvine, California, United States
• UAB St Vincents — Birmingham, Alabama, United States
• Eastern Shore Research Institute — Fairhope, Alabama, United States
• G and L Research LLC — Foley, Alabama, United States
• Alaska Heart and Vascular — Anchorage, Alaska, United States
• Mercy Gilbert Medical Center — Gilbert, Arizona, United States
• Cardiovascular Associates of Mesa — Mesa, Arizona, United States
• Elite Clinical Studies — Phoenix, Arizona, United States
• HonorHealth Heart Group Deer Valley — Scottsdale, Arizona, United States
• Clinical Research Inst of Arizona — Sun City West, Arizona, United States
• Pima Heart And Vascular Clin Rch — Tucson, Arizona, United States
• ARcare Center for Clinical Research — Little Rock, Arkansas, United States
• Arkansas Clinical Research — Little Rock, Arkansas, United States
• Central Cardiology Medical Center — Bakersfield, California, United States
• Alliance Clinical — Canoga Park, California, United States
• Inland Psychiatric Medical Group — Chino, California, United States
• John Muir Physician Network Clinical Research Center — Concord, California, United States
• Triallogix — Fullerton, California, United States
• UC San Diego Health — La Jolla, California, United States
• American Institute of Research — Los Angeles, California, United States
• Keck Medical Center USC — Los Angeles, California, United States
• University of California LA — Los Angeles, California, United States
• VA Palo Alto Health Care System — Palo Alto, California, United States
• San Diego Veterans Medical Center — San Diego, California, United States
• Diabetes Lipid Management Center — Huntington Beach, California, United States

Full record on ClinicalTrials.gov

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