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NCT05030428

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

17004 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-23

Study Completion Date

2027-10-13

Brief Summary

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Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

Detailed Description

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Purpose of this study is to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1, Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy.

Conditions

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Atherosclerotic Cardiovascular Disease

Keywords

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Atherosclerotic cardiovascular disease Hypercholesterolemia Dyslipidemia high cholesterol Hyperlipidemia Inclisiran siRNA KJX839

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double-blind, parallel group, placebo-controlled, multi-center, event-driven study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double-blind

Study Groups

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Inclisiran sodium

Subcutaneous injection

Group Type EXPERIMENTAL

Inclisiran sodium 300 mg

Intervention Type DRUG

Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit

Placebo

Subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

1. Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease \< 4 weeks before screening visit
2. Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit
3. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months after the first study visit
4. Heart failure NYHA class III or IV
5. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver
6. Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years
7. Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years
8. History of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit
9. Pregnant or nursing (lactating) women

Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

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CKJX839B12302

Identifier Type: -

Identifier Source: org_study_id

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Inclisiran sodium

Inclisiran sodium 300 mg

Placebo

Placebo

Interventions

Inclisiran sodium 300 mg

Placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Novartis Pharmaceuticals

Responsible Party

Principal Investigators

Novartis Pharmaceuticals

Locations

UAB St Vincents

Eastern Shore Research Institute

G and L Research LLC

Alaska Heart and Vascular

Mercy Gilbert Medical Center

Cardiovascular Associates of Mesa

Elite Clinical Studies

HonorHealth Heart Group Deer Valley

Clinical Research Inst of Arizona

Pima Heart And Vascular Clin Rch

ARcare Center for Clinical Research

Arkansas Clinical Research

Central Cardiology Medical Center

Alliance Clinical

Inland Psychiatric Medical Group

John Muir Physician Network Clinical Research Center

Triallogix

Diabetes Lipid Management Center

University of Calif Irvine Med Cntr

UC San Diego Health

American Institute of Research

Keck Medical Center USC

University of California LA

VA Palo Alto Health Care System

San Diego Veterans Medical Center

West Coast Research LLC

Helping Hands Medical Associates INC

Syrentis Clinical Research

Encompass Clinical Research

Stanford University Medical Center

Manshadi Heart Institute

Harbor UCLA Medical Center

Blue Coast Research Center LLC

Interv Cardiology Med Grp

Aurora Denver Cardiology Associates

Rocky Mountain Regional VA Med Ctr

Bridgeport Hospital

d-b-a Greenwich Cardio Assoc

Chase Medical Research LLC

Emerson Clinical Research Institute

Excel Medical Clinical Trials LLC

Cardiovascular and Vein Center of Florida

Nova Clinical Research LLC

Bay Care Medical Group

Cardiology Research Associates

Hillcrest Medical Research

Indago Research and Health Ctr Inc

National Research Institute

Sister Life Research Inc

Zenith Clinical Research

Westside Center for Clinical Research

UF Health Science Center

Baptist Heart Specialists

United Vein and Vascular Centers

Infinite Clinical Research