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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 (V-PLAQUE)

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Inclisiran sodium 300 mg
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Inclisiran, KJX839, Atherosclerotic plaques, CCTA, CT-adapted Leaman score, LDL-C, FFRct, NOCAD, PCSK9 inhibitor, TAV

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Inclisiran sodium

Arm Description

Subcutaneous injection

Subcutaneous injection

Outcomes

Primary Outcome Measures

Percentage change in total coronary atheroma volume
Evaluating inclisiran compared to placebo both on top of maximally tolerated statin therapy in reducing total coronary atheroma volume assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease (NOCAD) without previous cardiovascular events.

Secondary Outcome Measures

Percentage change in LDL-C
Full fasting lipid panel will be collected throughout the study beginning at baseline.
Percentage change in low attenuation plaque volume evaluated by CCTA
Evaluating inclisiran compared to placebo in percentage change in low attenuation plaque volume evaluated by CCTA.
Percentage of participants with progression, regression, or no change of total plaque atheroma volume
Evaluating inclisiran compared to placebo in percentage of participants experiencing progression, regression, or no change of total atheroma volume.

Full Information

First Posted
April 29, 2022
Last Updated
September 18, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05360446
Brief Title
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
Acronym
V-PLAQUE
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
January 2, 2026 (Anticipated)
Study Completion Date
January 2, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
The purpose of this study is to evaluate the efficacy of inclisiran compared to placebo on top of maximally tolerated statin therapy in reducing total coronary atheroma volume assessed by coronary computed tomography angiography from baseline to month 24 in participants with a diagnosis of NOCAD without previous cardiovascular events, a CT-adapted Leaman score >5 and a FFRct >0.8. Participants will either receive inclisiran 300 mg subcutaneously administered on Day 1, Month 3 (Day 90), and every 6 months up until Month 21. The study duration is 24 months. Participants will have a CCTA performed at baseline and at the month 24/end of study visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Inclisiran, KJX839, Atherosclerotic plaques, CCTA, CT-adapted Leaman score, LDL-C, FFRct, NOCAD, PCSK9 inhibitor, TAV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multi-center, randomized, double-blind, placebo-controlled, parallel-group
Masking
ParticipantCare ProviderInvestigator
Masking Description
Sponsor personnel participating in the study conducted will be blinded also.
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous injection
Arm Title
Inclisiran sodium
Arm Type
Experimental
Arm Description
Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Inclisiran sodium 300 mg
Intervention Description
Subcutaneously administered on Days 1, Month 3 (Day 90), and every 6 months thereafter.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneously administered on Day 1, Month 3 (Day 90), and every 6 months thereafter.
Primary Outcome Measure Information:
Title
Percentage change in total coronary atheroma volume
Description
Evaluating inclisiran compared to placebo both on top of maximally tolerated statin therapy in reducing total coronary atheroma volume assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease (NOCAD) without previous cardiovascular events.
Time Frame
From baseline to month 24
Secondary Outcome Measure Information:
Title
Percentage change in LDL-C
Description
Full fasting lipid panel will be collected throughout the study beginning at baseline.
Time Frame
From baseline to month 24
Title
Percentage change in low attenuation plaque volume evaluated by CCTA
Description
Evaluating inclisiran compared to placebo in percentage change in low attenuation plaque volume evaluated by CCTA.
Time Frame
From baseline to month 24
Title
Percentage of participants with progression, regression, or no change of total plaque atheroma volume
Description
Evaluating inclisiran compared to placebo in percentage of participants experiencing progression, regression, or no change of total atheroma volume.
Time Frame
From baseline to month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90509-2910
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fort Washington
State/Province
Maryland
ZIP/Postal Code
20744
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-3362
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ciudad Autonoma de Bs As
State/Province
Buenos Aires
ZIP/Postal Code
C1119ACN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1428DCO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chemside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milton
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Leabrook
State/Province
South Australia
ZIP/Postal Code
5068
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
80040-050
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90560 030
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sao Paulo
ZIP/Postal Code
01409-902
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M6B 3H7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Temuco
State/Province
Region De La Araucania
ZIP/Postal Code
4781156
Country
Chile
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santiago
State/Province
RM
ZIP/Postal Code
8380465
Country
Chile
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
211166
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Paris 13
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toulouse 4
ZIP/Postal Code
31054
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 017
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 060
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 069
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600081
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
DehraDun
State/Province
Uttarakhand
ZIP/Postal Code
248001
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700 107
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Coimbatore
ZIP/Postal Code
641 009
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
New Delhi
ZIP/Postal Code
110025
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dublin
ZIP/Postal Code
94568
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Galway
ZIP/Postal Code
H91
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kumamoto City
State/Province
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kyoto-city
State/Province
Kyoto
ZIP/Postal Code
607-8062
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Miyhazaki-city
State/Province
Miyazaki
ZIP/Postal Code
880-2102
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Urasoe
State/Province
Okinawa
ZIP/Postal Code
901-2132
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Izumisano-city
State/Province
Osaka
ZIP/Postal Code
598-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bundang Gu
State/Province
Gyeonggi Do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Goyang si
State/Province
Gyeonggi Do
ZIP/Postal Code
10380
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
07804
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Geneve 14
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lugano
ZIP/Postal Code
6903
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Craigavon
State/Province
Northern Ireland
ZIP/Postal Code
BT63 5QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

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

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