A Phase 3 interventional study of Inclisiran sodium 300 mg and Placebo in Atherosclerotic Cardiovascular Disease, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 983 sites in 50 countries. Open to participants aged 40 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
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).
Purpose of this study is to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1, Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy.
1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.
This study's enrollment of 17,004 is above the median of 100 across 879 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Established CV disease defined as ANY of the following three conditions
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subcutaneous injection
Drug: Inclisiran sodium 300 mg
Subcutaneous injection
Drug: Placebo
Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit
Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit
Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events)
3P-MACE is a confirmed composite endpoint which includes cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke.
Time frame: From randomization to total follow-up time (up to 72 months)
Time to Occurrence of Cardiovascular (CV) Death
CV death is defined as death due to cardiovascular events
Time frame: From randomization to total follow-up time (up to 72 months)
Time to First Occurrence of 4P-MACE (4-Point Major Adverse Cardiovascular Events)
A composite 4P- MACE is defined as CV death, non-fatal MI, non-fatal ischemic stroke and urgent coronary revascularization.
Time frame: From randomization to total follow-up time (up to 72 months)
Time to first occurrence of Major Limb Adverse Events (MALE)
Major Limb Adverse Events including acute lower limb ischemia, lower limb amputation due to ischemia, or urgent lower limb revascularization for ischemia
Time frame: From randomization to total follow-up time (up to 72 months)
Time to occurrence of all-cause death
All-Cause death is defined as: all deaths from randomization until up to 72 months
Time frame: From randomization to total follow-up time (up to 72 months)
Showing the first 100 of 983 sites across 50 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Started Nov 2021 (actual). Primary completion is estimated for May 2027, 65 months after the start.
Of 36 industry-sponsored phase 3 interventional studies under Atherosclerosis, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 51. This study's planned 65 months is above that.
Counting every sponsor, half of 53 studies reached it within 35 months; a quarter within 21 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Inclisiran