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

About

Brief Summary

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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

40 Years

Maximum Age

N/A

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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