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HPS 4/TIMI 65 ORION 4: A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease.

The HPS-4/TIMI 65/ORION-4 study aims to provide evidence about both the efficacy and safety of inclisiran. Consistent with relevant guideline recommendations for people with vascular disease, it is intended that participants be on intensive background LDL-lowering therapy, at screening. The primary efficacy outcome is 'major adverse cardiovascular events' ( MACE), which is the composite of coronary heart disease (CHD) death, myocardial infarction, fatal or non- fatal ischemic stroke or urgent coronary revascularization. 2.3.1.2 Additional assessments required by regulatory agencies Additional assessments required by regulatory agencies will involve intention-to-treat comparisons among all randomized participants of the effects of allocation to inclisiran versus placebo during the scheduled treatment period on time to first occurrence of: (i) The composite outcome of cardiovascular death, non-fatal myocardial infarction, nonfatal ischemic stroke or urgent coronary revascularization; (ii) The composite outcome of all-cause death, non-fatal myocardial infarction, non-fatal ischemic stroke, or urgent coronary revascularization procedure; and (iii) The composite outcome of cardiovascular death, non-fatal myocardial infarction or non-fatal ischemic stroke. 2.3.1.3 Secondary assessments Secondary assessments will involve intention-to-treat comparisons among all randomized participants of the effects of allocation to inclisiran versus placebo during the scheduled treatment period on time to first occurrence of: (i) The composite outcome of CHD death or myocardial infarction; and (ii) Cardiovascular death.

The HPS-4/TIMI 65/ORION-4 study aims to provide evidence about both the efficacy and safety of inclisiran. Consistent with relevant guideline recommendations for people with vascular disease, it is intended that participants be on intensive background LDL-lowering therapy, at screening. The primary efficacy outcome is 'major adverse cardiovascular events' ( MACE), which is the composite of coronary heart disease (CHD) death, myocardial infarction, fatal or non- fatal ischemic stroke or urgent coronary revascularization. 2.3.1.2 Additional assessments required by regulatory agencies Additional assessments required by regulatory agencies will involve intention-to-treat comparisons among all randomized participants of the effects of allocation to inclisiran versus placebo during the scheduled treatment period on time to first occurrence of: (i) The composite outcome of cardiovascular death, non-fatal myocardial infarction, nonfatal ischemic stroke or urgent coronary revascularization; (ii) The composite outcome of all-cause death, non-fatal myocardial infarction, non-fatal ischemic stroke, or urgent coronary revascularization procedure; and (iii) The composite outcome of cardiovascular death, non-fatal myocardial infarction or non-fatal ischemic stroke. 2.3.1.3 Secondary assessments Secondary assessments will involve intention-to-treat comparisons among all randomized participants of the effects of allocation to inclisiran versus placebo during the scheduled treatment period on time to first occurrence of: (i) The composite outcome of CHD death or myocardial infarction; and (ii) Cardiovascular death.