Atherosclerotic Cardiovascular Disease Clinical Trial
— SIRIUSOfficial title:
In Silico Non Interventional Secondary Use of Data Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease
Verified date | May 2024 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 204691 |
Est. completion date | December 15, 2023 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria : 1. Patients with atherosclerotic CV disease, defined as any of the following i. Previous MI ii. Previous ischemic stroke iii. Previous symptomatic peripheral arterial disease (PAD) as evidenced by either intermittent claudication with ABI <0.85, prior peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease 2. Fasting LDL-C = 70 mg/dL 3. Under stable (= 4 weeks) well-tolerated high-intensity statin with or without ezetimibe. Exclusion Criteria : Patients with acute coronary syndrome, ischemic stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease <4 weeks prior to the first study visit |
Country | Name | City | State |
---|---|---|---|
France | Novartis Investigative Site | Rueil-Malmaison |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 3P-MACE is a confirmed composite endpoint which includes cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke. | 5 years of follow-up | |
Primary | Time to the first occurrence between trial start and end of follow-up of CV death | CV death is defined as death due to cardiovascular events | 5 years of follow-up | |
Secondary | Time to the first occurrence between trial start and end of follow-up of MI (non-fatal or fatal) | Myocardial infarction (MI) | 5 years of follow-up | |
Secondary | 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 | ||
Secondary | Time to the first occurrence between trial start and end of follow-up of Major Adverse Limb events (MALE) | MALE include acute lower limb ischemia, lower limb amputation due to ischemia, or urgent lower limb revascularization for ischemia | 5 years of follow-up | |
Secondary | Change in LDL-C from baseline to specified time points | Low density lipoprotein cholesterol (LDL-C) | baseline, day 1, 30, 90 and every 6 months afterwards will be presented and additional time points could be added if deemed necessary. | |
Secondary | Time adjusted percentage change in LDL-C | This is the average percentage change in LDL-C from baseline over period from Day 90 and the end of follow-up period. | From baseline between Day 90 and the end of follow-up period (up to 5 years) |
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