Last Update: Aug 31, 2023
A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT) Identifier:
Novartis Reference Number:CKJX839B12302
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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).

Atherosclerotic Cardiovascular Disease
Phase 3
Nov 23, 2021
Oct 13, 2027
40 Years - (Adult, Older Adult)



Inclisiran sodium 300 mg

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

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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