In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease
- Conditions
- Atherosclerotic Cardiovascular Disease
- Interventions
- Registration Number
- NCT05974345
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Study CKJX839B1FR01 in an In silico trial to predict the efficacy of Inclisiran therapy on major adverse cardiovascular events (MACE) and cardiovascular (CV) death in virtual patients with atherosclerotic cardiovascular disease (ASCVD) and elevated LDL-C.
- Detailed Description
Purpose of this study is to predict the size of efficacy of inclisiran 300 mg s.c., administered on Day 1, Month 3 (Day 90), and every 6 months thereafter in addition to currently available lipid lowering therapies (LLTs) on a 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) or non-fatal ischemic stroke, and on CV death, in a secondary prevention cohort of ASCVD virtual patients with a LDL-C ≥ 70 mg/dL. This will be compared to 1) placebo in adjunct to high-intensity statin therapy with or without ezetimibe, 2) ezetimibe in adjunct to high-intensity statin therapy, 3) Evolocumab in adjunct to high-intensity statin therapy and ezetimibe.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204691
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Virtual Patient with ASCVD Inclisiran sodium Virtual Patient with ASCVD and LDL-C ≥ 70 mg/dL despite receiving a well-tolerated high-intensity statin with or without ezetimibe. Each virtual patient is his own control. Virtual Patient with ASCVD Placebo Virtual Patient with ASCVD and LDL-C ≥ 70 mg/dL despite receiving a well-tolerated high-intensity statin with or without ezetimibe. Each virtual patient is his own control. Virtual Patient with ASCVD Ezetimibe Virtual Patient with ASCVD and LDL-C ≥ 70 mg/dL despite receiving a well-tolerated high-intensity statin with or without ezetimibe. Each virtual patient is his own control. Virtual Patient with ASCVD Evolocumab Virtual Patient with ASCVD and LDL-C ≥ 70 mg/dL despite receiving a well-tolerated high-intensity statin with or without ezetimibe. Each virtual patient is his own control.
- Primary Outcome Measures
Name Time Method Time to the first occurrence between trial start and end of follow-up of any component of 3P-MACE (composite of CV death, non-fatal MI or non-fatal ischemic stroke) 5 years of follow-up 3P-MACE is a confirmed composite endpoint which includes cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke.
Time to the first occurrence between trial start and end of follow-up of CV death 5 years of follow-up CV death is defined as death due to cardiovascular events
- Secondary Outcome Measures
Name Time Method Time to the first occurrence between trial start and end of follow-up of ischemic stroke (non-fatal or fatal) 5 years of follow-up Time to the first occurrence between trial start and end of follow-up of MI (non-fatal or fatal) 5 years of follow-up Myocardial infarction (MI)
Time to the first occurrence between trial start and end of follow-up of Major Adverse Limb events (MALE) 5 years of follow-up MALE include acute lower limb ischemia, lower limb amputation due to ischemia, or urgent lower limb revascularization for ischemia
Change in LDL-C from baseline to specified time points baseline, day 1, 30, 90 and every 6 months afterwards will be presented and additional time points could be added if deemed necessary. Low density lipoprotein cholesterol (LDL-C)
Time adjusted percentage change in LDL-C From baseline between Day 90 and the end of follow-up period (up to 5 years) This is the average percentage change in LDL-C from baseline over period from Day 90 and the end of follow-up period.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇫🇷Rueil-Malmaison, France