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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

610

Participants

Timeline

Start Date

July 8, 2022

Primary Completion Date

October 26, 2026

Study Completion Date

October 26, 2026

Conditions
Coronary Artery Disease
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.

Trial Locations (89)

1211

Novartis Investigative Site, Geneva

2300

Novartis Investigative Site, Turnhout

3500

Novartis Investigative Site, Hasselt

3600

Novartis Investigative Site, Genk

4032

Novartis Investigative Site, Chemside

4064

Novartis Investigative Site, Milton

4066

Novartis Investigative Site, Auchenflower

5068

Novartis Investigative Site, Leabrook

5530

Novartis Investigative Site, Yvoir

6720

Novartis Investigative Site, Szeged

6903

Novartis Investigative Site, Lugano

9300

Novartis Investigative Site, Aalst

10029

Icahn School of Med at Mt Sinai, New York

10126

Novartis Investigative Site, Torino

10380

Novartis Investigative Site, Goyang-si

10595

Westchester Medical Center, Valhalla

13620

Novartis Investigative Site, Bundang Gu

14004

Novartis Investigative Site, Córdoba

15006

Novartis Investigative Site, A Coruña

20037

George Washington Univ Medical Ctr, Washington D.C.

20089

Novartis Investigative Site, Rozzano

20138

Novartis Investigative Site, Milan

20157

Novartis Investigative Site, Milan

20744

Anderson Medical Research, Ft. Washington

22042

Inova Fairfax Hospital, Falls Church

Virginia Heart, Falls Church

28034

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

31054

Novartis Investigative Site, Toulouse

33014

Inpatient Research Clinical LLC, Miami Lakes

33604

Novartis Investigative Site, Pessac

35801

Heart Center Research Llc, Huntsville

37007

Novartis Investigative Site, Salamanca

44710

Aultman Hospital, Canton

46010

Novartis Investigative Site, Valencia

47374

Reid Physician Associates, Richmond

55407

Minneapolis Heart Institute, Minneapolis

60201

NorthShore University Health System, Evanston

66211

Midwest Heart and Vascular Spec, Overland Park

75013

Novartis Investigative Site, Paris

75226

Soltero Cardiovascular Research Center, Dallas

77034

Orion Medical, Houston

86021

Novartis Investigative Site, Poitiers

89502

R Ins For Heart And Vascular Health, Reno

90210

Cardiovascular Res Found, Beverly Hills

92037

UC San Diego Health, La Jolla

94305

Stanford Health Care, Stanford

97239

Oregon Health Sciences University, Portland

98122

Swedish Medical Center-Cardiovascular Research, Seattle

98195

Univ of Washington Medical Center, Seattle

99508

Alaska Heart and Vascular, Anchorage

100029

Novartis Investigative Site, Beijing

100050

Novartis Investigative Site, Beijing

110025

Novartis Investigative Site, New Delhi

200080

Novartis Investigative Site, Shanghai

211166

Novartis Investigative Site, Nanjing

226003

Novartis Investigative Site, Lucknow

248001

Novartis Investigative Site, Dehradun

600006

Novartis Investigative Site, Chennai

8380465

Novartis Investigative Site, Santiago

90509-2910

Lundquist Inst BioMed at Harbor, Torrance

06610

Bridgeport Hospital, Bridgeport

08873

Cardio Metabolic Institute, Somerset

11794-3362

State Uni of NY at Stony Brook, Stony Brook

C1428DCO

Novartis Investigative Site, Buenos Aires

C1119ACN

Novartis Investigative Site, Ciudad Autonoma de Bs As

80040-050

Novartis Investigative Site, Curitiba

90560 030

Novartis Investigative Site, Porto Alegre

01409-902

Novartis Investigative Site, São Paulo

M6B 3H7

Novartis Investigative Site, North York

K1Y 4W7

Novartis Investigative Site, Ottawa

H1T 1C8

Novartis Investigative Site, Montreal

H-1083

Novartis Investigative Site, Budapest

560 069

Novartis Investigative Site, Bangalore

110 017

Novartis Investigative Site, New Delhi

110 060

Novartis Investigative Site, New Delhi

641 009

Novartis Investigative Site, Coimbatore

D03 VX82

Novartis Investigative Site, Dublin

H91 YR71

Novartis Investigative Site, Galway

880-2102

Novartis Investigative Site, Miyhazaki-city

901-2102

Novartis Investigative Site, Urasoe

598-8577

Novartis Investigative Site, Izumisano

607-8062

Novartis Investigative Site, Kyoto

03722

Novartis Investigative Site, Seoul

07804

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

08041

Novartis Investigative Site, Barcelona

ED16 4SA

Novartis Investigative Site, Edinburgh

NE7 7DN

Novartis Investigative Site, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY