A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis [Lp(a)FRONTIERS CAVS]
1 other identifier
interventional
502
15 countries
139
Brief Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2024
Longer than P75 for phase_2
139 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2022
CompletedFirst Posted
Study publicly available on registry
December 12, 2022
CompletedStudy Start
First participant enrolled
March 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 12, 2030
April 15, 2026
April 1, 2026
6 years
December 2, 2022
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in peak aortic jet velocity
To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography
36 months
Change in aortic valve calcium score
To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in aortic valve calcium score by computed tomography
36 months
Secondary Outcomes (3)
Change in Lp(a) levels
12 months
Change in fibrocalcific thickening of the aortic valve
36 months
Time from randomization to first occurrence of composite clinical endpoint event
Up to 36 months
Study Arms (2)
Pelacarsen (TQJ230) 80mg
EXPERIMENTALPelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously
Matching placebo
PLACEBO COMPARATORPlacebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously
Interventions
Eligibility Criteria
You may qualify if:
- Male and female ≥50 to \<80 years of age at Screening Part II
- Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
- Mild or moderate calcific aortic valve stenosis
- At the randomization visit, participant must be optimally treated for existing CV risk factors
You may not qualify if:
- Severe calcific aortic valve stenosis
- Uncontrolled hypertension
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count ≤ LLN
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Pregnant or nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (139)
Heart Center Research Llc
Huntsville, Alabama, 35801, United States
Cardiovascular Res Found
Beverly Hills, California, 90210, United States
National Heart Institute
Beverly Hills, California, 90211, United States
Flourish Clinical Resrch Covin
Covina, California, 91723, United States
Valley Clinical Trials
Northridge, California, 91325, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
University Of California San Diego
San Diego, California, 92103-8415, United States
UC San Francisco Medical Center
San Francisco, California, 94143, United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434, United States
Nova Clinical Research LLC
Bradenton, Florida, 34209, United States
Flourish Res Acq LLC North Miami
Miami, Florida, 33138, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014, United States
Advanced Research for Health Improvement LLC
Naples, Florida, 34102, United States
Midwest Heart and Vascular Spec
Overland Park, Kansas, 66211, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, 02115, United States
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, 02115, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
AA Medical Research Center
Flint, Michigan, 48504, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073-4192, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
University Of Minnesota
Minneapolis, Minnesota, 55455, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
Capital Cardiology Associates
Albany, New York, 12211, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
Icahn School of Med at Mt Sinai
New York, New York, 10029, United States
Strong Memorial Hospital
Rochester, New York, 14642, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Lindner Ctr At The Christ Hosp
Cincinnati, Ohio, 45219, United States
Ohio State University
Columbus, Ohio, 43210, United States
Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Orion Medical
Houston, Texas, 77034, United States
Virginia Heart
Falls Church, Virginia, 22042, United States
Carient Heart and Vascular
Manassas, Virginia, 20109, United States
Novartis Investigative Site
Innsbruck, Tyrol, 6020, Austria
Novartis Investigative Site
Linz, 4021, Austria
Novartis Investigative Site
Vienna, 1100, Austria
Novartis Investigative Site
Vienna, 1190, Austria
Novartis Investigative Site
Vienna, A 1090, Austria
Novartis Investigative Site
Genk, Limburg, 3600, Belgium
Novartis Investigative Site
Yvoir, Namur, 5530, Belgium
Novartis Investigative Site
Aalst, Oost Vlaanderen, 9300, Belgium
Novartis Investigative Site
Kortrijk, West-Vlaanderen, 8500, Belgium
Novartis Investigative Site
Roeselare, West-Vlaanderen, 8800, Belgium
Novartis Investigative Site
Cambridge, Ontario, N1R 6V6, Canada
Novartis Investigative Site
North York, Ontario, M6B 3H7, Canada
Novartis Investigative Site
Ottawa, Ontario, K1Y 4W7, Canada
Novartis Investigative Site
Montreal, Quebec, H1T 1C8, Canada
Novartis Investigative Site
Montreal, Quebec, H3T 1E2, Canada
Novartis Investigative Site
Montreal, Quebec, H4A 3J1, Canada
Novartis Investigative Site
Québec, Quebec, G1V 4G5, Canada
Novartis Investigative Site
Hradec Králové, 500 02, Czechia
Novartis Investigative Site
Jaroměř, 551 01, Czechia
Novartis Investigative Site
Prague, 128 08, Czechia
Novartis Investigative Site
Prague, 14021, Czechia
Novartis Investigative Site
Prague, 150 06, Czechia
Novartis Investigative Site
Esbjerg, 6700, Denmark
Novartis Investigative Site
Hvidovre, 2650, Denmark
Novartis Investigative Site
Roskilde, 4000, Denmark
Novartis Investigative Site
Viborg, 8800, Denmark
Novartis Investigative Site
Paris, 75012, France
Novartis Investigative Site
Paris, 75013, France
Novartis Investigative Site
Paris, 75015, France
Novartis Investigative Site
Pessac, 33604, France
Novartis Investigative Site
Poitiers, 86021, France
Novartis Investigative Site
Rennes, 35033, France
Novartis Investigative Site
Frankfurt am Main, Hesse, 60594, Germany
Novartis Investigative Site
Kaiserslautern, Rhineland-Palatinate, 67655, Germany
Novartis Investigative Site
Dresden, Saxony, 01099, Germany
Novartis Investigative Site
Leipzig, Saxony, 04289, Germany
Novartis Investigative Site
Ahaus, 48683, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Bonn, 53105, Germany
Novartis Investigative Site
Essen, 45147, Germany
Novartis Investigative Site
Hamburg, 20246, Germany
Novartis Investigative Site
Hamburg, 22763, Germany
Novartis Investigative Site
Lüneburg, 21339, Germany
Novartis Investigative Site
Mannheim, 68165, Germany
Novartis Investigative Site
München, 80636, Germany
Novartis Investigative Site
Münster, 48149, Germany
Novartis Investigative Site
Oldenburg, 26133, Germany
Novartis Investigative Site
Beersheba, 8457108, Israel
Novartis Investigative Site
Haifa, 3104802, Israel
Novartis Investigative Site
Haifa, 3109601, Israel
Novartis Investigative Site
Jerusalem, 9103102, Israel
Novartis Investigative Site
Jerusalem, 9112001, Israel
Novartis Investigative Site
Nahariya, 2210001, Israel
Novartis Investigative Site
Petah Tikva, 4941492, Israel
Novartis Investigative Site
Ramat Gan, 5265601, Israel
Novartis Investigative Site
Tel Aviv, 6423906, Israel
Novartis Investigative Site
Ancona, AN, 60126, Italy
Novartis Investigative Site
Bergamo, BG, 24127, Italy
Novartis Investigative Site
Bologna, BO, 40138, Italy
Novartis Investigative Site
Brescia, BS, 25123, Italy
Novartis Investigative Site
Caserta, CE, 81100, Italy
Novartis Investigative Site
Cona, FE, 44124, Italy
Novartis Investigative Site
Pozzilli, IS, 86077, Italy
Novartis Investigative Site
Milan, MI, 20138, Italy
Novartis Investigative Site
Milan, MI, 20157, Italy
Novartis Investigative Site
Milan, MI, 20162, Italy
Novartis Investigative Site
Padova, PD, 35128, Italy
Novartis Investigative Site
Pordenone, PN, 33170, Italy
Novartis Investigative Site
Amsterdam, North Holland, 1090 HM, Netherlands
Novartis Investigative Site
Amsterdam, North Holland, 1105 AZ, Netherlands
Novartis Investigative Site
Rotterdam, South Holland, 3015 GD, Netherlands
Novartis Investigative Site
Rotterdam, South Holland, 3079 DZ, Netherlands
Novartis Investigative Site
Nieuwegein, Utrecht, 3435 CM, Netherlands
Novartis Investigative Site
Alcabideche, 2755-009, Portugal
Novartis Investigative Site
Braga, 4710243, Portugal
Novartis Investigative Site
Coimbra, 3004-561, Portugal
Novartis Investigative Site
Vila Nova de Gaia, 4434 502, Portugal
Novartis Investigative Site
Cáceres, Extremadura, 10003, Spain
Novartis Investigative Site
Córdoba, 14004, Spain
Novartis Investigative Site
Madrid, 28034, Spain
Novartis Investigative Site
Madrid, 28040, Spain
Novartis Investigative Site
Madrid, 28041, Spain
Novartis Investigative Site
Madrid, 28046, Spain
Novartis Investigative Site
Salamanca, 37007, Spain
Novartis Investigative Site
Valencia, 46010, Spain
Novartis Investigative Site
Basel, 4031, Switzerland
Novartis Investigative Site
Geneva, 1211, Switzerland
Novartis Investigative Site
Lausanne, 1011, Switzerland
Novartis Investigative Site
Lugano, 6900, Switzerland
Novartis Investigative Site
Zurich, 8091, Switzerland
Novartis Investigative Site
Reading, Berkshire, RG1 5AN, United Kingdom
Novartis Investigative Site
Portadown, Nothern Ireland, BT63 5QQ, United Kingdom
Novartis Investigative Site
Edinburgh, ED16 4SA, United Kingdom
Novartis Investigative Site
Leicester, LE3 9QP, United Kingdom
Novartis Investigative Site
Liverpool, L14 3PE, United Kingdom
Novartis Investigative Site
London, EC1A 7BE, United Kingdom
Novartis Investigative Site
London, SE1 7EH, United Kingdom
Novartis Investigative Site
Londonderry, BT47 6SB, United Kingdom
Novartis Investigative Site
Manchester, M23 9LT, United Kingdom
Novartis Investigative Site
Middlesbrough, TS4 3BW, United Kingdom
Novartis Investigative Site
Norwich, NR4 7UY, United Kingdom
Novartis Investigative Site
Tyne and Wear, NE29 8NH, United Kingdom
Related Publications (1)
Nicholls SJ, Nelson AJ, Michael LF. Oral agents for lowering lipoprotein(a). Curr Opin Lipidol. 2024 Dec 1;35(6):275-280. doi: 10.1097/MOL.0000000000000953. Epub 2024 Sep 25.
PMID: 39329200DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 2, 2022
First Posted
December 12, 2022
Study Start
March 7, 2024
Primary Completion (Estimated)
March 12, 2030
Study Completion (Estimated)
March 12, 2030
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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 the applicable laws and regulations.