Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardio… (NCT05030428) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
United States17,004 participantsStarted 2021-11-23
Plain-language 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).
Who can participate
Age range40 Years – 100 Years
SexALL
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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
✕
What they're measuring
1
Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events)
Timeframe: From randomization to total follow-up time (up to 72 months)