A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
Launched by NOVARTIS PHARMACEUTICALS · Dec 2, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called pelacarsen (TQJ230) to see if it can help slow down the worsening of calcific aortic valve stenosis, a condition where the heart's aortic valve becomes narrowed, making it harder for the heart to pump blood. The treatment is given as an injection under the skin once a month. Researchers want to find out if pelacarsen is safe, effective, and easy to tolerate compared to a placebo, which is a shot with no active medication.
To participate in this study, you need to be between 50 and 80 years old and have a specific level of lipoprotein(a), a type of fat in the blood, as well as mild to moderate aortic valve stenosis. You should also be receiving the right treatment for other heart-related risk factors. However, individuals with severe aortic stenosis, uncontrolled high blood pressure, or certain health conditions like active liver disease or a history of major bleeding are not eligible. If you join the trial, you'll receive regular check-ups and monitoring to ensure your safety and to see how well the treatment is working.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male and female ≥50 to \<80 years of age
- • 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
- Exclusion Criteria:
- • 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
- • Other protocol-defined inclusion/exclusion criteria may apply
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Minneapolis, Minnesota, United States
Columbus, Ohio, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Stanford, California, United States
Boston, Massachusetts, United States
Winston Salem, North Carolina, United States
New York, New York, United States
Rochester, New York, United States
Minneapolis, Minnesota, United States
Montreal, Quebec, Canada
Roskilde, , Denmark
Madrid, , Spain
Winston Salem, North Carolina, United States
Yvoir, , Belgium
Poitiers, , France
Berlin, , Germany
Hamburg, , Germany
Bologna, Bo, Italy
Basel, , Switzerland
Sainte Foy, Quebec, Canada
Essen, , Germany
Padova, Pd, Italy
Zuerich, , Switzerland
Lausanne, , Switzerland
Ancona, An, Italy
Aalst, , Belgium
Viborg, , Denmark
Muenster, , Germany
Jerusalem, , Israel
Pessac, , France
London, , United Kingdom
Petach Tikva, , Israel
Ramat Gan, , Israel
Paris, , France
Pessac Cedex, , France
Haifa, , Israel
Cona, Fe, Italy
Bergamo, Bg, Italy
Salamanca, Castilla Y Leon, Spain
Valencia, Comunidad Valenciana, Spain
Genk, , Belgium
Kortrijk, , Belgium
Esbjerg, , Denmark
Viborg, , Denmark
Cambridge, Ontario, Canada
Hvidovre, , Denmark
Caserta, Ce, Italy
Pozzilli, Is, Italy
Lugano, , Switzerland
Edinburgh, , United Kingdom
Brescia, Bs, Italy
Huntsville, Alabama, United States
Innsbruck, Tyrol, Austria
Caceres, Extremadura, Spain
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Esbjerg, , Denmark
Frankfurt, , Germany
Muenchen, , Germany
Milano, Mi, Italy
Amsterdam, , Netherlands
Paris, , France
Falls Church, Virginia, United States
Summit, New Jersey, United States
Nahariya, , Israel
Ramat Gan, , Israel
New York, New York, United States
Hamburg, , Germany
Londonderry, , United Kingdom
Rotterdam, , Netherlands
Praha 4, Czech Republic, Czechia
Northridge, California, United States
Praha, , Czechia
Middlesbrough, , United Kingdom
Leicester, , United Kingdom
London, , United Kingdom
Oldenburg, , Germany
Linz, , Austria
Braga, , Portugal
Coimbra, , Portugal
Dresden, Sachsen, Germany
Petach Tikva, , Israel
Vila Nova De Gaia, , Portugal
Tyne And Wear, , United Kingdom
Geneve 14, , Switzerland
Philadelphia, Pennsylvania, United States
Beer Sheva, , Israel
Pordenone, , Italy
Boca Raton, Florida, United States
San Diego, California, United States
Boston, Massachusetts, United States
Prague 4, , Czechia
Manassas, Virginia, United States
Flint, Michigan, United States
Detroit, Michigan, United States
Naples, Florida, United States
Dresden, Saxonia, Germany
Wien, , Austria
Beverly Hills, California, United States
North York, Ontario, Canada
Paris 13, , France
Beverly Hills, California, United States
Miami Lakes, Florida, United States
New York, New York, United States
Boston, Massachusetts, United States
Huntsville, Alabama, United States
Prague 2, , Czechia
Columbus, Ohio, United States
Overland Park, Kansas, United States
Lueneburg, , Germany
Jaromer Budova Polikliniky, , Czechia
Rennes, , France
Beer Sheva, , Israel
Torrette Ancona, An, Italy
Winston Salem, North Carolina, United States
Boston, Massachusetts, United States
San Francisco, California, United States
Cincinnati, Ohio, United States
Hradec Kralove, , Czechia
Frankfurt Am Main, Hessen, Germany
Royal Oak, Michigan, United States
Cincinnati, Ohio, United States
Haifa, , Israel
Nahariya, , Israel
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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