A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Pat… (NCT06431763) | Clinical Trial Compass
CompletedPhase 4
A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.
Germany402 participantsStarted 2024-06-21
Plain-language summary
This study is a phase IV, open-label, randomized study designed to evaluate the efficacy of Inclisiran vs. bempedoic acid (BPA) in 400 adult subjects (≥ 18 years) at very high and high risk for cardiovascular events as defined by the cardiovascular risk categories in the 2019 ESC/EAS guidelines for the management of dyslipidemias (Mach et al 2020) and elevated levels of LDL-C (≥ 70 mg/dL) despite being on a maximally tolerated high-intensity (HI) statin dose (+/- Ezetimibe). Currently, BPA is recommended ahead of injectables by German HTA body (GBA). A head-to-head trial is proposed to provide robust scientific data on the superiority of Inclisiran vs. BPA and to support the early use of Inclisiran.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Fasting LDL-C ≥ 70 mg/dL at screening
✓. Participants must be on a stable (≥ 4 weeks) and well-tolerated lipid-lowering regimen (with or without Ezetimibe \[10mg\]) that must include a high-intensity statin therapy with either atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD in a maximally tolerated or maximally approved dose at screening
✓. Participants categorized as very high or high CV risk, as defined below:
✓. Fasting triglyceride \< 400 mg/dL at screening
Exclusion criteria
✕. Acute coronary syndrome, ischemic stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease \< 4 months prior to screening visit or V1.
✕. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or coronary re-vascularization within 6 months after screening visit.
✕. Heart failure NYHA class IV at screening or V1.
✕. Participants on more than one other lipid-lowering drug on top of statin at screening visit.