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

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase IIIb Study Evaluating the Effect of Inclisiran on Atherosclerotic Plaque Progression Assessed by Coronary Computed Tomography Angiography (CCTA) in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events (VICTORION-PLAQUE)

ClinicalTrials.gov Identifier: NCT05360446

Novartis Reference Number: CKJX839D12303

Last Update: Nov 24, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Coronary Artery Disease
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Jul 08, 2022
Completion date 
Jul 18, 2025
Gender 
All
Age(s)
18 Years - 80 Years (Adult, Older Adult)

Interventions

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

Eligibility Criteria

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 if on statin therapy but not on a maximally tolerated statin therapy; ii) ≥150 mg/dL if statin naive and without documented statin intolerance; or iii) ≥70 mg/dL if on a stable (≥4 weeks) dose of maximally tolerated statin therapy or if statin intolerant.
Participants may be pre-identified based on a CCTA or an invasive angiography that is performed as part of standard of care within 12 months prior to the participant's Screening Visit demonstrating:
Presence of coronary artery plaque with visual diameter stenosis <50% or
Coronary artery plaque with visual artery stenosis >50% but Fractional Flow Reserve (FFR) >0.8 by special wire measurement (CCTA or coronary angiography)
Fasting LDL-C local lab value ≥70 mg/dL at the assessment performed during the Statin Optimization Period 3 Visit for participants going through the Statin Optimization Period.

Participants having Non-Obstructive Coronary Artery (NOCA)* confirmed by CCTA with FFRct >0.8 and CT-adapted Leaman score >5** or coronary artery plaque with visual diameter stenosis >50% but with FFRct >0.8 and CT-adapted Leaman score >5 without previous cardiovascular events.

*=NOCA is defined as the presence of coronary artery plaque with visual diameter stenosis <50%.

**=CT-adapted Leaman score, which includes information on lesion localization, plaque composition, degree of stenosis by CCTA is demonstrated to be an independent long-term predictor of hard cardiac events.

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.

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.
NOCA participant who was prescreened by the Investigator with visual diameter stenosis >50% but FFR <0.8.
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. Participants who enter the Statin Optimization Period must have AST and ALT ≤3x ULN (as defined by local laboratory reference ranges collected at the Screening Visit) and reported by the Statin Optimization Telephone Visit 1 to be allowed to continue in the Statin Optimization Period.

Study Locations

United States
Novartis Investigative Site
Recruiting
Huntsville, 35801
Alabama
United States
Novartis Investigative Site
Recruiting
Anchorage, 99508
Alaska
United States
Novartis Investigative Site
Recruiting
Beverly Hills, 90210
California
United States
Novartis Investigative Site
Recruiting
Torrance, 90509-2910
California
United States
Novartis Investigative Site
Recruiting
Richmond, 47374
Indiana
United States
Novartis Investigative Site
Recruiting
Overland Park, 66211
Kansas
United States
Novartis Investigative Site
Recruiting
Reno, 89502
Nevada
United States
Novartis Investigative Site
Recruiting
New York, 10029
New York
United States
Novartis Investigative Site
Recruiting
Canton, 44710
Ohio
United States
Novartis Investigative Site
Recruiting
Dallas, 75226
Texas
United States
Novartis Investigative Site
Recruiting
Falls Church, 22042
Virginia
United States
Australia
Novartis Investigative Site
Recruiting
Auchenflower, 4066
Queensland
Australia
Novartis Investigative Site
Recruiting
Chemside, 4032
Queensland
Australia
Novartis Investigative Site
Recruiting
Milton, 4064
Queensland
Australia
Novartis Investigative Site
Recruiting
Leabrook, 5068
South Australia
Australia
Belgium
Novartis Investigative Site
Recruiting
Genk, 3600
-
Belgium
Novartis Investigative Site
Recruiting
Hasselt, 3500
-
Belgium
Novartis Investigative Site
Recruiting
Turnhout, 2300
-
Belgium
Brazil
Novartis Investigative Site
Recruiting
Curitiba, 80040-050
PR
Brazil
Novartis Investigative Site
Recruiting
Porto Alegre, 90560 030
RS
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 01409-902
-
Brazil
Chile
Novartis Investigative Site
Recruiting
Temuco, 4781156
Region De La Araucania
Chile
Novartis Investigative Site
Recruiting
Santiago, 8380465
RM
Chile
China
Novartis Investigative Site
Recruiting
Nanjing, 211166
Jiangsu
China
Novartis Investigative Site
Recruiting
Beijing, 100029
-
China
Novartis Investigative Site
Recruiting
Beijing, 100050
-
China
France
Novartis Investigative Site
Recruiting
Paris, 75015
-
France
Novartis Investigative Site
Recruiting
Paris,
-
France
Novartis Investigative Site
Recruiting
Poitiers, 86021
-
France
Novartis Investigative Site
Recruiting
Toulouse Cedex, 31059
-
France
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1085
-
Hungary
Novartis Investigative Site
Recruiting
Szeged, 6720
-
Hungary
Ireland
Novartis Investigative Site
Recruiting
Dublin,
-
Ireland
Novartis Investigative Site
Recruiting
Galway,
-
Ireland
Italy
Novartis Investigative Site
Recruiting
Rozzano, 20089
MI
Italy
Spain
Novartis Investigative Site
Recruiting
Valencia, 46010
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08041
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28034
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28040
-
Spain
Switzerland
Novartis Investigative Site
Recruiting
Geneve 14, 1211
-
Switzerland
Novartis Investigative Site
Recruiting
Lugano, 6903
-
Switzerland
United Kingdom
Novartis Investigative Site
Recruiting
Edinburgh, EH16 4SA
-
United Kingdom
Novartis Investigative Site
Recruiting
London, SE5 9RS
-
United Kingdom
Novartis Investigative Site
Recruiting
Newcastle upon Tyne, NE7 7DN
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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