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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

PHASE3RECRUITING

CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s. c. ) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.

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Study details:

The purpose of this study is to evaluate inclisiran sodium 300 mg s. c. (equivalent to 284 mg inclisiran) compared to placebo on reducing the risk of 4P-MACE in adult patients at high risk for their first major adverse cardiovascular event.

Randomized participants will receive study medication (inclisiran or placebo), administered s. c. on Day 1, Day 90, then every 6 months thereafter.

This is an event-driven study. Therefore, the study will continue until the required number of clinical events have occurred across both treatment arms, and all participants have a minimum of 3 years of follow-up during the double-blind treatment period.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following: 1. 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 other major epicardial coronary artery, or 2. Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or 3. High 10-year ASCVD risk ≥20%, or 4. Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors.

LDL-C ≥70 mg/dL (≥1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit. If on a background lipid lowering therapy, 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.

Exclusion criteria

History of major ASCVD event.

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 which includes for 6 months after last study drug administration.

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Eligibility

Age eligible for study : 40 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-03-09

Primary completion: 2029-03-08

Study completion finish: 2029-03-08

Study type

PREVENTION

Phase

PHASE3

Trial ID

NCT05739383

Intervention or treatment

DRUG: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

DRUG: Placebo in 1.5ml

Conditions

• Primary Prevention of Atherosclerotic Cardiovascular Disease

Image related to Primary Prevention of Atherosclerotic Cardiovascular Disease

Condition: Primary Prevention of Atherosclerotic Cardiovascular Disease
DRUG: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL and other drugs
Canberra, Australian Capital Territory, Australia and more
Sponsor: Novartis Pharmaceuticals

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Novartis Investigative Site

Research sites nearby

Select from list below to view details:

Novartis Investigative Site
Canberra, Australian Capital Territory, Australia
Novartis Investigative Site
Auchenflower, Queensland, Australia
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
Leabrook, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Inclisiran sodium 300mg Inclisiran sodium 300 mg in 1.5 mL solution for injection (subcutaneous) in pre-filled syringe. Randomized in a 1:1 ratio with matching placebo	DRUG: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL Subcutaneous injection in pre-filled syringe.
PLACEBO_COMPARATOR: Placebo Matching placebo in 1.5ml pre-filled syringe. Randomized in a 1:1 ratio with Inclisiran.	DRUG: Placebo in 1.5ml Matching placebo in 1.5ml solution for injection

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Time to the first occurrence of 4P-MACE	4-Point-Major Adverse Cardiovascular Events (4P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization.	Time to the first occurrence of 4P-MACE (up to approximately 75 months)

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Time to the first occurrence of 3P-MACE	3-Point-Major Adverse Cardiovascular Events (3P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke)	Time to the first occurrence of 3P-MACE (up to approximately 75 months)
Total number of first or repeated CV events (4P MACE)	Total 4P-MACE (composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization)	up to 75 months
Total number of first or repeated CV events (3P MACE)	Total 3P-MACE (composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke)	up to 75 months
Time to occurrence of Cardiovascular death	CV death is defined as death due to cardiovascular events.	Time to Cardiovascular death (up to 75 months)
Time to occurrence of death due to any reason	All-cause mortality is death due to any reason.	Time to all-cause mortality (up to 75 months)

Frequently Asked Questions

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References

Clinical Trials Gov: A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.