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Clinical Trials in the USA / NCT05360446
Active, not recruiting Phase 3

Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events

NCT05360446 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2022-07-08
Last updated
2026-07-13

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Inclisiran sodium 300 mgPlacebo

Inclisiran sodium 300 mg: Subcutaneously administered on Days 1, Month 3 (Day 90), and every 6 months thereafter.

Placebo: Subcutaneously administered on Day 1, Month 3 (Day 90), and every 6 months thereafter.

Study summary

CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24. This study is being conducted in eligible participants with a diagnosis of non-obstructive coronary artery disease (NOCAD), where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Male or female ≥18 years or ≤80 years of age at signing of informed consent. * Fasting LDL-C local lab value at the Screening Visit of either i) ≥100 mg/dL (2.6 mmol/L) if on statin therapy but not on a maximally tolerated statin therapy; ii) ≥150 mg/dL (3.9mmol/L) if statin naive and without documented statin intolerance; or iii) ≥55 mg/dL (1.4 mmol/L) if on a stable (≥4 weeks) dose of maximally tolerated statin therapy or if statin intolerant. * Fasting LDL-C local lab value ≥55 mg/dL (1.4 mmol/L) at the assessment performed during the Statin Optimization Period 3 Visit for participants going through the Statin Optimization Period. * Participants having NOCAD without previous cardiovascular events: NOCAD is defined as:. 1. Participant with CT-adapted Leaman score \>5. and a diameter stenosis \<50% or 2. Participants with a CT-adapted Leaman score \>5, a diameter stenosis ≥50% but with FFRCT ≥0.76. * A standard of care CCTA may serve as the study baseline CCTA scan if it is performed within 3 months prior to the participant's Screening Visit and meets the inclusion criteria of FFRct \>0.8 and CT-adapted Leaman score \>5, which will be assessed by the Imaging Core Lab. * At the Baseline Visit, participants must be on a stable (≥4 weeks) dose of maximally tolerated statin therapy. Participants not on maximally tolerated statin therapy and who do not have documented statin intolerance can be screened but must enter the study via a Statin Optimization Period. * Fasting LDL-C lab value ≥55 mg/dL (1.4 mmol/L) at the Baseline Visit, measured at the central laboratory. If the Baseline and Screening Visits occur on the same day, then the LDL-C assessment will be assessed on the central laboratory sample. If a participant qualifies at Screening but the fasting central lab LDL-C value at the Baseline visit does not meet eligibility, then eligibility will be determined based on the central lab result. * Fasting triglycerides value \<400 mg/dL (4.52 mmol/L) based on the local lab results at the Screening visit and on the central lab results at the CCTA visit. Exclusion Criteria: * Previous cardiovascular events history including myocardial infarction (MI), or prior coronary revascularization \[percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)\]. * Planned revascularization (PCI) or (CABG). * Previous cerebrovascular events including: * Prior ischemic stroke thought not to be caused by atrial fibrillation, valvular heart disease or mural thrombus. * History of prior percutaneous or surgical carotid artery revascularization. * History of Peripheral Artery Disease (PAD): * Prior documentation of a resting ankle-brachial index \<0.85. * History of prior percutaneous or surgical revascularization of an iliac, femoral, or popliteal artery. * Prior non-traumatic amputation of a lower extremity due to peripheral artery disease. * Cardiac disorders, including any of the following: * Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, atrial fibrillation) within 3 months prior to randomization that is not controlled by medication or via ablation at the time of the Screening Visit. * Complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block) prior to randomization. * Contraindication for CCTA (e.g., allergic reactions to the contrast dye) or CCTA not meeting entry standards after two attempts during the Baseline CCTA Visit as assessed by the Imaging Core Lab. * Pacemaker or implantable cardioverter-defibrillator (ICD) in situ. * Systolic Left Ventricle Ejection Fraction \<30% at the Screening Visit. * Uncontrolled severe hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization (assessed at the Screening Visit) despite antihypertensive therapy. * Heart failure New York Heart Association (NYHA) class III or class IV at the Screening Visit. * Renal insufficiency (eGFR \<30 mL/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the Screening Visit and at the Statin Optimization 3 Visit. * Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit. * Local creatine kinase (CK) values of either, unless a more stringent threshold is mandated by a local regulatory authority * Local CK values ≥5x ULN at the Statin Optimization 3 Visit unless a more stringent threshold is mandated by a local regulatory authority * Participant with myopathy at the Statin Optimization 3 Visit.

Primary outcome measure(s)

Trial sites (89)

FacilityCityRegionStatus
Heart Center Research Llc Huntsville Alabama
Alaska Heart and Vascular Anchorage Alaska
Cardiovascular Res Found Beverly Hills California
UC San Diego Health La Jolla California
Stanford Health Care Stanford California
Lundquist Inst BioMed at Harbor Torrance California
Bridgeport Hospital Bridgeport Connecticut
George Washington Univ Medical Ctr Washington D.C. District of Columbia
Inpatient Research Clinical LLC Miami Lakes Florida
NorthShore University Health System Evanston Illinois
Reid Physician Associates Richmond Indiana
Midwest Heart and Vascular Spec Overland Park Kansas
Anderson Medical Research Ft. Washington Maryland
Minneapolis Heart Institute Minneapolis Minnesota
R Ins For Heart And Vascular Health Reno Nevada
Cardio Metabolic Institute Somerset New Jersey
Icahn School of Med at Mt Sinai New York New York
State Uni of NY at Stony Brook Stony Brook New York
Westchester Medical Center Valhalla New York
Aultman Hospital Canton Ohio
Oregon Health Sciences University Portland Oregon
Soltero Cardiovascular Research Center Dallas Texas
Orion Medical Houston Texas
Inova Fairfax Hospital Falls Church Virginia
Virginia Heart Falls Church Virginia
Swedish Medical Center-Cardiovascular Research Seattle Washington
Univ of Washington Medical Center Seattle Washington
Novartis Investigative Site Caba Buenos Aires
Novartis Investigative Site Buenos Aires Argentina
Novartis Investigative Site Auchenflower Queensland
Novartis Investigative Site Chemside Queensland
Novartis Investigative Site Milton Queensland
Novartis Investigative Site Leabrook South Australia
Novartis Investigative Site Turnhout Antwerpen
Novartis Investigative Site Genk Limburg
Novartis Investigative Site Hasselt Limburg
Novartis Investigative Site Yvoir Namur
Novartis Investigative Site Aalst Oost Vlaanderen
Novartis Investigative Site Curitiba Paraná
Novartis Investigative Site Porto Alegre Rio Grande do Sul

+ 49 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05360446 on ClinicalTrials.gov ↗ ← All trials in the USA