Study Description
The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C). This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.
Interventions
Inclisiran
Pelacarsen
Placebo
Eligibility Criteria
Key Inclusion criteria:
* Male and female participants 18 to ≤80 years of age at Screening visit
* Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit
* On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit
* Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized
* On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit
* Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit
* Central laboratory reported LDL-C \>70 mg/dL (or \>1.8 mmol/L) at Screening visit
Key Exclusion Criteria:
* Prior treatment with inclisiran
* Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit
* Uncontrolled hypertension at Randomization/Baseline visit
* Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)
* Triglycerides ≥400 mg/dL at Screening visit
* History of malignancy of any organ system within the past 5 years
* Myocardial infarction, stroke or other major bleeding, coronary or lower limb re vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1)
* Central laboratory reported platelet count \<140,000 per mm3
* Active liver disease or hepatic dysfunction at Screening visit
* Significant kidney disease at Screening visit
* Pregnant or nursing women at Screening visit
* Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit
* Other protocol-defined inclusion/exclusion criteria may apply.
Novartis Investigative Site
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Xian,Shanxi,710061,China
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Beijing,100730,China
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Jining,Shandong,272000,China
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Shanghai,200025,China
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Yinchuan,Ningxia,750004,China
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Pessac,33604,France
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Poitiers,86021,France
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Stuttgart,Baden-Wurttemberg,70376,Germany
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Potsdam,Brandenburg,14473,Germany
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Berlin,10789,Germany
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Bielefeld,33604,Germany
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Gelnhausen,63571,Germany
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Mannheim,68165,Germany
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Münster,48145,Germany
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Singen,78224,Germany
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Hong Kong,Hong Kong,999077,Hong Kong
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Ancona,AN,60126,Italy
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Caserta,CE,81100,Italy
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Grosseto,GR,58100,Italy
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Milan,MI,20138,Italy
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Rozzano,MI,20089,Italy
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The Hague,South Holland,2545 aa,Netherlands
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Enschede,7512kz,Netherlands
Latin Clinical Trial Center Inc
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San Juan,00909,Puerto Rico
Alex Gonzalez Bossolo
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Santiago Compostela,A Coruna,15706,Spain
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Pamplona,Navarre,31008,Spain
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Castilleja de la Cuesta,Sevilla,41950,Spain
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A Coruña,15006,Spain
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Barcelona,08023,Spain
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Córdoba,14004,Spain
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Huelva,21080,Spain
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Las Palmas GC,35010,Spain
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Salamanca,37007,Spain
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Valencia,46014,Spain
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Taipei,11217,Taiwan
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Changhua,50006,Taiwan
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Kaohsiung City,80756,Taiwan
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Tainan,704,Taiwan
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Taipei,10002,Taiwan
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Chichester,West Sussex,Po19 6se,United Kingdom
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London,Ec1m 6bq,United Kingdom
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Tyne and Wear,Ne29 8nh,United Kingdom
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London,W12 0hs,United Kingdom
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Manchester,M13 9wl,United Kingdom
Excel Medical Clinical Trials LLC
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Boca Raton,Florida,33434,United States
Rimsky Denis
Inpatient Research Clinical LLC
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Miami Lakes,Florida,33014,United States
Alexis Gutierrez
Jose Casola
Jose Contreras
Omega Clinical Research
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Metairie,Louisiana,70006,United States
Tuan-Huy Tran
Henry Ford Hospital
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Detroit,Michigan,48202,United States
Khaled Abdul-Nour
Northwest Houston Clinical Research PLLC
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Tomball,Texas,77375,United States
Shamaila Aslam
FC Site Partners Miami
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Winter Park,Florida,32789,United States
Claisha Pruitt
Monica Aggarwal
Virginia Heart
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Falls Church,Virginia,22042,United States
Tariq Haddad
National Heart Institute
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Beverly Hills,California,90211,United States
Norman Lepor
Cardiovascular Associates Research
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Covington,Louisiana,70433,United States
Dale Presser
Overlook Medical Center
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Summit,New Jersey,07901,United States
Betty Merveil-Ceneus
Robert Fishberg
Anderson Medical Research
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Ft. Washington,Maryland,20744,United States
Ann-Marie Cobb
Felton Anderson
Clinical Research Inst of Arizona
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Sun City West,Arizona,85375,United States
Jalal Abbas
Jacksonville Center for Clinical
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Jacksonville,Florida,32216,United States
Michael J Koren
University of Miami Hospital
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Miami,Florida,33136,United States
Andrew Bromley
Maria Alamanzar
AB Clinical Trials
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Las Vegas,Nevada,89119,United States
Atoya Adams
MyMichigan Medical Center Midland
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Midland,Michigan,48670,United States
William Roy Felten
Novartis Investigative Site
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Tullahoma,Tennessee,37388,United States
Dinesh Gupta
Ocala Cardiovascular Research
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Ocala,Florida,34471,United States
Arleana Brown
Lan Luo
SEC Clinical Research
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Pensacola,Florida,32503,United States
Robert I Garver
Peace River Cardiovascular Center
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Port Charlotte,Florida,33952,United States
David Allan Hotchkiss
American Health Network Research Dept
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Muncie,Indiana,47304,United States
Andrew Daluga
Jonathan Condit
PharmaTex Research LLC
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Amarillo,Texas,79106,United States
David Brabham
Kelsey Seybold Research Foundation
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Houston,Texas,77030,United States
Fisayomi Shobayo
Parkway Medical Center
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Birmingham,Alabama,35215,United States
James Sullivan
Interv Cardiology Med Grp
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West Hills,California,91307,United States
Farhad Rafii
Miami Cancer Institute at Bapt
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Miami,Florida,33173,United States
Adedapo Iluyomade
FXM Clin Res Miramar LLC
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Miramar,Florida,33027,United States
Yaneth Trujillo
Advocate Lutheran General Childrens Hospital
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Park Ridge,Illinois,60068,United States
Adib Chaus
Marina Kelly
Wake Forest University Baptist Medical Center
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Winston-Salem,North Carolina,27157,United States
Keishia Rodriguez
Michael Shapiro
The Corvallis Clinic P C
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Corvallis,Oregon,97330,United States
Daniel P. Barrett
Intermountain Medical Center
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Murray,Utah,84107,United States
Jeffrey Anderson
K2 Medical Research LLC
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Maitland,Florida,32751,United States
Evette Trahan
Neel Patel
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