Phase
Condition
Vascular Diseases
Atherosclerosis
Thrombosis
Treatment
Placebo
Inclisiran sodium 300 mg
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 (2.6mmol/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; oriii) ≥55 mg/dL (1.4 mmol/L) if on a stable (≥4 weeks) dose of maximally toleratedstatin therapy or if statin intolerant.
Fasting LDL-C local lab value ≥55 mg/dL (1.4 mmol/L) at the assessment performedduring the Statin Optimization Period 3 Visit for participants going through theStatin Optimization Period.
Participants having NOCAD without previous cardiovascular events: NOCAD is definedas:.
Participant with CT-adapted Leaman score >5. and a diameter stenosis <50% or
Participants with a CT-adapted Leaman score >5, a diameter stenosis ≥50% butwith FFRCT ≥0.76.
A standard of care CCTA may serve as the study baseline CCTA scan if it is performedwithin 3 months prior to the participant's Screening Visit and meets the inclusioncriteria of FFRct >0.8 and CT-adapted Leaman score >5, which will be assessed by theImaging Core Lab.
At the Baseline Visit, participants must be on a stable (≥4 weeks) dose of maximallytolerated statin therapy. Participants not on maximally tolerated statin therapy andwho do not have documented statin intolerance can be screened but must enter thestudy via a Statin Optimization Period.
Fasting LDL-C lab value ≥55 mg/dL (1.4 mmol/L) at the Baseline Visit, measured atthe 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 aparticipant qualifies at Screening but the fasting central lab LDL-C value at theBaseline visit does not meet eligibility, then eligibility will be determined basedon the central lab result.
Fasting triglycerides value <400 mg/dL (4.52 mmol/L) based on the local lab resultsat the Screening visit and on the central lab results at the CCTA visit.
Exclusion
Exclusion Criteria:
Previous cardiovascular events history including myocardial infarction (MI), orprior coronary revascularization [percutaneous coronary intervention (PCI) orcoronary artery bypass graft (CABG)].
Planned revascularization (PCI) or (CABG).
Previous cerebrovascular events including:
Prior ischemic stroke thought not to be caused by atrial fibrillation, valvularheart 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 arterydisease.
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 notcontrolled 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 torandomization.
Contraindication for CCTA (e.g., allergic reactions to the contrast dye) or CCTA notmeeting entry standards after two attempts during the Baseline CCTA Visit asassessed 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 diastolicblood 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 theScreening Visit.
Renal insufficiency (eGFR <30 mL/min/1.73m2) as measured by the Modification of Dietin Renal Disease (MDRD) formula at the Screening Visit and at the StatinOptimization 3 Visit.
Active liver disease defined as any known current infectious, neoplastic, ormetabolic pathology of the liver at the Screening Visit.
Local creatine kinase (CK) values of either, unless a more stringent threshold ismandated by a local regulatory authority
Local CK values ≥5x ULN at the Statin Optimization 3 Visit unless a more stringentthreshold is mandated by a local regulatory authority
Participant with myopathy at the Statin Optimization 3 Visit.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires C1119ACN
ArgentinaSite Not Available
Novartis Investigative Site
Buenos Aires, C1428DCO
ArgentinaSite Not Available
Novartis Investigative Site
Auchenflower, Queensland 4066
AustraliaSite Not Available
Novartis Investigative Site
Chemside, Queensland 4032
AustraliaSite Not Available
Novartis Investigative Site
Milton, Queensland 4064
AustraliaSite Not Available
Novartis Investigative Site
Leabrook, South Australia 5068
AustraliaSite Not Available
Novartis Investigative Site
Joondalup, Western Australia 6027
AustraliaSite Not Available
Novartis Investigative Site
Murdoch, Western Australia 6150
AustraliaSite Not Available
Novartis Investigative Site
Aalst, 9300
BelgiumSite Not Available
Novartis Investigative Site
Genk, 3600
BelgiumSite Not Available
Novartis Investigative Site
Hasselt, 3500
BelgiumSite Not Available
Novartis Investigative Site
Turnhout, 2300
BelgiumSite Not Available
Novartis Investigative Site
Yvoir, 5530
BelgiumSite Not Available
Novartis Investigative Site
Curitiba, PR 80040-050
BrazilSite Not Available
Novartis Investigative Site
Porto Alegre, RS 90560 030
BrazilSite Not Available
Novartis Investigative Site
Sao Paulo, 01409-902
BrazilSite Not Available
Novartis Investigative Site
North York, Ontario M6B 3H7
CanadaSite Not Available
Novartis Investigative Site
Ottawa, Ontario K1Y 4W7
CanadaSite Not Available
Novartis Investigative Site
Montreal, Quebec H1T 1C8
CanadaSite Not Available
Novartis Investigative Site
Santiago, RM 8380465
ChileSite Not Available
Novartis Investigative Site
Temuco, Region De La Araucania 4781156
ChileSite Not Available
Novartis Investigative Site
Nanjing, Jiangsu 211166
ChinaSite Not Available
Novartis Investigative Site
Hangzhou, Zhejiang 310016
ChinaSite Not Available
Novartis Investigative Site
Beijing, 100050
ChinaSite Not Available
Novartis Investigative Site
Shanghai, 200080
ChinaSite Not Available
Novartis Investigative Site
Paris, 75013
FranceSite Not Available
Novartis Investigative Site
Paris 13, 75651
FranceSite Not Available
Novartis Investigative Site
Paris Cedex 13, 75651
FranceSite Not Available
Novartis Investigative Site
Pessac, 33604
FranceSite Not Available
Novartis Investigative Site
Pessac Cedex, 33604
FranceSite Not Available
Novartis Investigative Site
Poitiers, 86021
FranceSite Not Available
Novartis Investigative Site
Toulouse, 31054
FranceSite Not Available
Novartis Investigative Site
Toulouse 4, 31054
FranceSite Not Available
Novartis Investigative Site
Toulouse Cedex, 31059
FranceSite Not Available
Novartis Investigative Site
Toulouse Cedex 4, 31054
FranceSite Not Available
Novartis Investigative Site
Budapest, H-1083
HungarySite Not Available
Novartis Investigative Site
Szeged, 6720
HungarySite Not Available
Novartis Investigative Site
Bangalore, Karnataka 560 069
IndiaSite Not Available
Novartis Investigative Site
Chennai, Tamil Nadu 600006
IndiaSite Not Available
Novartis Investigative Site
Lucknow, Uttar Pradesh 226003
IndiaSite Not Available
Novartis Investigative Site
Dehradun, Uttarakhand 248001
IndiaSite Not Available
Novartis Investigative Site
Kolkata, West Bengal 700 107
IndiaSite Not Available
Novartis Investigative Site
Coimbatore, 641 009
IndiaSite Not Available
Novartis Investigative Site
New Delhi, 110025
IndiaSite Not Available
Novartis Investigative Site
Dublin, D03 VX82
IrelandSite Not Available
Novartis Investigative Site
Galway, H91 YR71
IrelandSite Not Available
Novartis Investigative Site
Milano, MI 20138
ItalySite Not Available
Novartis Investigative Site
Rozzano, MI 20089
ItalySite Not Available
Novartis Investigative Site
Torino, TO 10126
ItalySite Not Available
Novartis Investigative Site
Kumamoto City, Kumamoto 860-8556
JapanSite Not Available
Novartis Investigative Site
Kyoto-city, Kyoto 607-8062
JapanSite Not Available
Novartis Investigative Site
Miyhazaki-city, Miyazaki 880-2102
JapanSite Not Available
Novartis Investigative Site
Urasoe, Okinawa 901-2102
JapanSite Not Available
Novartis Investigative Site
Izumisano-city, Osaka 598-8577
JapanSite Not Available
Novartis Investigative Site
Kumamoto, 860-8556
JapanSite Not Available
Novartis Investigative Site
Kyoto, 607-8062
JapanSite Not Available
Novartis Investigative Site
Bundang Gu, Gyeonggi Do 13620
Korea, Republic ofSite Not Available
Novartis Investigative Site
Goyang si, Gyeonggi do 10380
Korea, Republic ofSite Not Available
Novartis Investigative Site
Seoul, 07804
Korea, Republic ofSite Not Available
Novartis Investigative Site
Salamanca, Castilla Y Leon 37007
SpainSite Not Available
Novartis Investigative Site
Barcelona, Catalunya 08035
SpainSite Not Available
Novartis Investigative Site
A Coruna, Galicia 15006
SpainSite Not Available
Novartis Investigative Site
Cordoba, 14004
SpainSite Not Available
Novartis Investigative Site
Madrid, 28034
SpainSite Not Available
Novartis Investigative Site
Valencia, 46010
SpainSite Not Available
Novartis Investigative Site
Geneve 14, 1211
SwitzerlandSite Not Available
Novartis Investigative Site
Lugano, 6903
SwitzerlandSite Not Available
Novartis Investigative Site
Craigavon, Northern Ireland BT63 5QQ
United KingdomSite Not Available
Novartis Investigative Site
Portadown, Nothern Ireland BT63 5QQ
United KingdomSite Not Available
Novartis Investigative Site
Bradford, West Yorkshire BD9 6RJ
United KingdomSite Not Available
Novartis Investigative Site
Edinburgh, ED16 4SA
United KingdomSite Not Available
Novartis Investigative Site
London, SE5 9RS
United KingdomSite Not Available
Novartis Investigative Site
Newcastle upon Tyne, NE7 7DN
United KingdomSite Not Available
Heart Center Research Llc
Huntsville, Alabama 35801
United StatesSite Not Available
Heart Center Research Llc .
Huntsville, Alabama 35801
United StatesActive - Recruiting
Heart Center Research, LLC .
Huntsville, Alabama 35801
United StatesActive - Recruiting
Novartis Investigative Site
Huntsville, Alabama 35801
United StatesActive - Recruiting
Alaska Heart and Vascular
Anchorage, Alaska 99508
United StatesSite Not Available
Novartis Investigative Site
Anchorage, Alaska 99508
United StatesActive - Recruiting
Cardiovascular Res Found
Beverly Hills, California 90210
United StatesSite Not Available
Novartis Investigative Site
Beverly Hills, California 90210
United StatesActive - Recruiting
Novartis Investigative Site
La Jolla, California 92037
United StatesActive - Recruiting
UC San Diego Health
La Jolla, California 92037
United StatesSite Not Available
UC San Diego Health .
La Jolla, California 92037
United StatesActive - Recruiting
Novartis Investigative Site
Stanford, California 94305
United StatesActive - Recruiting
Stanford Health Care
Stanford, California 94305
United StatesSite Not Available
Stanford Health Care .
Stanford, California 94305
United StatesActive - Recruiting
Lundquist Inst BioMed at Harbor
Torrance, California 90509-2910
United StatesSite Not Available
Lundquist Inst BioMed at Harbor UCLA Medical Center
Torrance, California 90509-2910
United StatesActive - Recruiting
Novartis Investigative Site
Torrance, California 90509-2910
United StatesActive - Recruiting
Bridgeport Hospital
Bridgeport, Connecticut 06610
United StatesSite Not Available
Bridgeport Hospital .
Bridgeport, Connecticut 06610
United StatesActive - Recruiting
Novartis Investigative Site
Bridgeport, Connecticut 06610
United StatesActive - Recruiting
George Washington Univ Medical Ctr
Washington, District of Columbia 20037
United StatesSite Not Available
Novartis Investigative Site
Washington, District of Columbia 20010
United StatesActive - Recruiting
Washington Hospital Center
Washington, District of Columbia 20010
United StatesActive - Recruiting
Washington Hospital Center Drug Ship
Washington, District of Columbia 20010
United StatesActive - Recruiting
Washington Hospital Center Medstar
Washington, District of Columbia 20010
United StatesActive - Recruiting
MCVI Baptist Hlth of S FL
Miami, Florida 33173
United StatesSite Not Available
Novartis Investigative Site
Miami, Florida 33173
United StatesActive - Recruiting
Inpatient Research Clinical LLC
Miami Lakes, Florida 33014
United StatesSite Not Available
NorthShore University Health System
Evanston, Illinois 60201
United StatesSite Not Available
NorthShore University Health System .
Evanston, Illinois 60201
United StatesActive - Recruiting
NorthShore University Health System Endeavor Health Glenbrook Hosp
Evanston, Illinois 60201
United StatesActive - Recruiting
Novartis Investigative Site
Evanston, Illinois 60201
United StatesActive - Recruiting
Novartis Investigative Site
Richmond, Indiana 47374
United StatesActive - Recruiting
Reid Physician Associates
Richmond, Indiana 47374
United StatesSite Not Available
Novartis Investigative Site
Kansas City, Kansas 66160
United StatesActive - Recruiting
The Uni of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
Midwest Heart and Vascular Spec
Overland Park, Kansas 66211
United StatesSite Not Available
Midwest Heart and Vascular Spec .
Overland Park, Kansas 66211
United StatesActive - Recruiting
Novartis Investigative Site
Overland Park, Kansas 66211
United StatesActive - Recruiting
Novartis Investigative Site
Louisville, Kentucky 40202
United StatesActive - Recruiting
U of Louisville Rudd Heart and Lung
Louisville, Kentucky 40202
United StatesSite Not Available
Anderson Medical Research
Fort Washington, Maryland 20744
United StatesSite Not Available
Anderson Medical Research Main Center
Fort Washington, Maryland 20744
United StatesActive - Recruiting
Novartis Investigative Site
Fort Washington, Maryland 20744
United StatesActive - Recruiting
Minneapolis Heart Institute
Minneapolis, Minnesota 55407
United StatesSite Not Available
Novartis Investigative Site
Minneapolis, Minnesota 55407
United StatesActive - Recruiting
Novartis Investigative Site
Reno, Nevada 89502
United StatesActive - Recruiting
R Ins For Heart And Vascular Health
Reno, Nevada 89502
United StatesSite Not Available
R Ins For Heart And Vascular Health .
Reno, Nevada 89502
United StatesActive - Recruiting
Cardio Metabolic Institute
Somerset, New Jersey 08873
United StatesSite Not Available
Cardio Metabolic Institute Research
Somerset, New Jersey 08873
United StatesActive - Recruiting
Novartis Investigative Site
Somerset, New Jersey 08873
United StatesActive - Recruiting
Icahn School of Med at Mt Sinai
New York, New York 10029
United StatesSite Not Available
Icahn School of Med at Mt Sinai .
New York, New York 10029
United StatesActive - Recruiting
Novartis Investigative Site
New York, New York 10029
United StatesActive - Recruiting
Novartis Investigative Site
Stony Brook, New York 11794-3362
United StatesActive - Recruiting
State Uni of NY at Stony Brook
Stony Brook, New York 11794-3362
United StatesSite Not Available
State Uni of NY at Stony Brook .
Stony Brook, New York 11794-3362
United StatesActive - Recruiting
Novartis Investigative Site
Valhalla, New York 10595
United StatesActive - Recruiting
Westchester Medical Center
Valhalla, New York 10595
United StatesSite Not Available
Westchester Medical Center .
Valhalla, New York 10595
United StatesActive - Recruiting
Aultman Hospital
Canton, Ohio 44710
United StatesSite Not Available
Aultman Hospital Main Centre
Canton, Ohio 44710
United StatesSite Not Available
Novartis Investigative Site
Canton, Ohio 44710
United StatesActive - Recruiting
Novartis Investigative Site
Portland, Oregon 97239
United StatesActive - Recruiting
Oregon Health Sciences University
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health Sciences University Main Center
Portland, Oregon 97239
United StatesActive - Recruiting
Lankenau Hospital
Wynnewood, Pennsylvania 19096
United StatesSite Not Available
Novartis Investigative Site
Wynnewood, Pennsylvania 19096
United StatesActive - Recruiting
Novartis Investigative Site
Dallas, Texas 75226
United StatesActive - Recruiting
Soltero Cardiovascular Research Center
Dallas, Texas 75226
United StatesSite Not Available
Soltero Cardiovascular Research Center .
Dallas, Texas 75226
United StatesActive - Recruiting
Soltero Cardiovascular Research Ctr .
Dallas, Texas 75226
United StatesActive - Recruiting
Novartis Investigative Site
Houston, Texas 77034
United StatesActive - Recruiting
Orion Medical
Houston, Texas 77034
United StatesSite Not Available
Novartis Investigative Site
Pasadena, Texas 77505
United StatesSite Not Available
Inova Fairfax Hospital
Falls Church, Virginia 22042
United StatesSite Not Available
Inova Fairfax Hospital .
Falls Church, Virginia 22042
United StatesSite Not Available
Novartis Investigative Site
Falls Church, Virginia 22042
United StatesActive - Recruiting
Virginia Heart
Falls Church, Virginia 22042
United StatesSite Not Available
Novartis Investigative Site
Seattle, Washington 98195
United StatesActive - Recruiting
Swedish Medical Center-Cardiovascular Research
Seattle, Washington 98122
United StatesSite Not Available
Swedish Medical Center-Cardiovascular Research .
Seattle, Washington 98122
United StatesActive - Recruiting
Swedish Medical Center/Cardiovascular Research .
Seattle, Washington 98122
United StatesActive - Recruiting
Swedish Medical Ctr Cardiovascular Re .
Seattle, Washington 98122
United StatesActive - Recruiting
Univ of Washington Medical Center
Seattle, Washington 98195
United StatesSite Not Available
Univ of Washington Medical Center .
Seattle, Washington 98195
United StatesActive - Recruiting
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