Open Actively Recruiting
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
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).
- 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.
- 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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