Health Condition 1: I709- Other and unspecified atherosclerosis
Conditions
Interventions
Intervention1: Inclisiran (also referred to as KJX839): One 300mg Inclisiran in 1.5 mL, sc Injections
Given on- Day1, Day 90 then followed by every 6 month
Control Intervention1: Placebo: One Placebo
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female aged >=40 years of age Fasting LDL-C >=1.8 mmol/L (70 mg/dL) at the Screening Visit At the Screening Visit, participants must be on a stable (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 40 mg QD or rosuvastatin 20 mg QD Established CV disease defined as any of the following: Previous myocardial infarction Previous ischemic stroke Previous symptomatic PAD, as evidenced by either intermittent claudication with ABI
Exclusion criteria
Exclusion criteria: ACS, ischemic stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease Treatment with PCSK9 monoclonal antibodies (e.g., evolocumab, alirocumab) within 90 days Previous exposure to inclisiran or any other non-mAb PCSK9 targeted therapy, either as an investigational or marketed drug within the prior 2 years Active liver disease (Participants who enter the Statin Optimization Period must have AST and ALT NYHA class III & IV heart failure Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 5 years Women of child-bearing potential, unless they are using effective methods of contraception during the course of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 3P-MACE (cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke) in participants with established ASCVD and LDL-C â?¥1.8 mmol/L (70 mg/dL) Timepoint: Assessment time point- starting from 3 months post baseline till end of study at a 6 monthly interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate the superiority of inclisiran compared to placebo in reducing the risk of cardiovascular death To demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 4P-MACE (composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization) To evaluate inclisiran compared to placebo in reducing the risk of all-cause death Timepoint: End point- Time to Death or Time to first occurrence of any of the component of 4P-MACE | — |
Countries
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, France, Georgia, Germany, Hungary, India, Israel, Italy, Japan, Kenya, Latvia, Lithuania, Malaysia, Mauritius, Mexico, Netherlands, New Zealand, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United States of America
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed