A study of inclisiran to prevent cardiovascular events in high-risk primary prevention patients
- Conditions
- Health Condition 1: I709- Other and unspecified atherosclerosis
- Registration Number
- CTRI/2023/06/053820
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:
a.Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis =20% but <50% in the left main coronary artery or stenosis =20% but <70% in any major epicardial coronary artery, or
b.Coronary artery calcium (CAC) score obtained by CT-scan =100 Agatston units, or
c.High 10-year ASCVD risk =20%, or
d.Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors.
If on a background LLT, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study.
Statin requirements are found in Section 4.1.1.
LDL-C =70 mg/dL (=1.81 mmol/L) but <190 mg/dL ( <4.91 mmol/L) at the screening visit.
History of major ASCVD event defined as any one of the following:
a.Acute coronary syndrome (ACS) in the 12 months prior to randomization, or
b.Prior myocardial infarction at any time prior to randomization, or
c.Prior ischemic stroke at any time prior to randomization, or
d.Symptomatic peripheral artery disease (PAD) as evidenced by either intermittent claudication, previous revascularization, or amputation due to atherosclerotic disease at any time prior to randomization.
History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization
Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization
Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization
Active liver disease or hepatic dysfunction
Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab)
Pregnant or nursing (lactating) women
Women of childbearing potential unless they are using effective methods of contraception while taking study treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 4P-MACE (composite of CV death, non-fatal MI, non-fatal ischemic stroke, and urgent coronary revascularization)Timepoint: Time to the first occurrence of 4P-MACE at every visit.
- Secondary Outcome Measures
Name Time Method To demonstrate the superiority of inclisiran compared to placebo in reducing the rate of total 3P-MACETimepoint: Times to the occurrences of CV death, non-fatal MI, and non-fatal ischemic stroke (first and recurrent);To demonstrate the superiority of inclisiran compared to placebo in reducing the rate of total 4P-MACETimepoint: Times to the occurrences of CV death, non-fatal MI, non-fatal ischemic stroke, and urgent coronary revascularization (first and recurrent);To demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI, and non-fatal ischemic stroke)Timepoint: Time to the first occurrence of 3P-MACE;To demonstrate the superiority of inclisiran compared to placebo in reducing the risk of all-cause mortalityTimepoint: Time to all-cause mortality;To demonstrate the superiority of inclisiran compared to placebo in reducing the risk of CV deathTimepoint: Time to CV death