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]
Status: Recruiting
Location: See all (134) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Heart Center Research Llc
RECRUITING
Huntsville
California
Cardiovascular Res Found
RECRUITING
Beverly Hills
National Heart Institute
RECRUITING
Beverly Hills
Flourish Clinical Resrch Covin
RECRUITING
Covina
Valley Clinical Trials
RECRUITING
Northridge
Stanford University Medical Center
RECRUITING
Palo Alto
University Of California San Diego
RECRUITING
San Diego
UC San Francisco Medical Center
RECRUITING
San Francisco
Florida
Excel Medical Clinical Trials LLC
WITHDRAWN
Boca Raton
Nova Clinical Research LLC
RECRUITING
Bradenton
Flourish Res Acq LLC North Miami
RECRUITING
Miami
Inpatient Research Clinical LLC
RECRUITING
Miami Lakes
Advanced Research for Health Improvement LLC
ACTIVE_NOT_RECRUITING
Naples
Kansas
Midwest Heart and Vascular Spec
RECRUITING
Overland Park
Massachusetts
Brigham and Womens Hosp Harvard Med School
RECRUITING
Boston
Brigham and Womens Hosp Harvard Med School
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Michigan
Henry Ford Hospital
RECRUITING
Detroit
Henry Ford Hospital
RECRUITING
Detroit
AA Medical Research Center
RECRUITING
Flint
William Beaumont Hospital
RECRUITING
Royal Oak
Minnesota
Minneapolis Heart Institute
WITHDRAWN
Minneapolis
University Of Minnesota
RECRUITING
Minneapolis
North Carolina
Wake Forest University Baptist Medical Center
RECRUITING
Winston-salem
New Jersey
Overlook Medical Center
RECRUITING
Summit
New York
Capital Cardiology Associates
RECRUITING
Albany
Icahn School of Med at Mt Sinai
RECRUITING
New York
New York Presbyterian Hospital
ACTIVE_NOT_RECRUITING
New York
Strong Memorial Hospital
RECRUITING
Rochester
Ohio
Lindner Ctr At The Christ Hosp
RECRUITING
Cincinnati
Ohio State University
WITHDRAWN
Columbus
Pennsylvania
Perelman School of Medicine
RECRUITING
Philadelphia
Texas
Orion Medical
RECRUITING
Houston
Virginia
Virginia Heart
RECRUITING
Falls Church
Carient Heart and Vascular
RECRUITING
Manassas
Other Locations
Austria
Novartis Investigative Site
RECRUITING
Innsbruck
Novartis Investigative Site
WITHDRAWN
Linz
Novartis Investigative Site
RECRUITING
Vienna
Novartis Investigative Site
RECRUITING
Vienna
Novartis Investigative Site
RECRUITING
Vienna
Belgium
Novartis Investigative Site
RECRUITING
Aalst
Novartis Investigative Site
RECRUITING
Genk
Novartis Investigative Site
RECRUITING
Kortrijk
Novartis Investigative Site
RECRUITING
Roeselare
Novartis Investigative Site
RECRUITING
Yvoir
Canada
Novartis Investigative Site
RECRUITING
Cambridge
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
North York
Novartis Investigative Site
RECRUITING
Ottawa
Novartis Investigative Site
RECRUITING
Québec
Denmark
Novartis Investigative Site
RECRUITING
Esbjerg
Novartis Investigative Site
RECRUITING
Hvidovre
Novartis Investigative Site
RECRUITING
Roskilde
Novartis Investigative Site
RECRUITING
Viborg
France
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Pessac
Novartis Investigative Site
RECRUITING
Poitiers
Novartis Investigative Site
RECRUITING
Rennes
Germany
Novartis Investigative Site
RECRUITING
Ahaus
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Bonn
Novartis Investigative Site
RECRUITING
Dresden
Novartis Investigative Site
RECRUITING
Essen
Novartis Investigative Site
RECRUITING
Frankfurt Am Main
Novartis Investigative Site
RECRUITING
Hamburg
Novartis Investigative Site
RECRUITING
Hamburg
Novartis Investigative Site
RECRUITING
Kaiserslautern
Novartis Investigative Site
RECRUITING
Leipzig
Novartis Investigative Site
WITHDRAWN
Lüneburg
Novartis Investigative Site
RECRUITING
Mannheim
Novartis Investigative Site
RECRUITING
München
Novartis Investigative Site
RECRUITING
Münster
Novartis Investigative Site
RECRUITING
Oldenburg
Israel
Novartis Investigative Site
RECRUITING
Beersheba
Novartis Investigative Site
RECRUITING
Haifa
Novartis Investigative Site
RECRUITING
Haifa
Novartis Investigative Site
RECRUITING
Jerusalem
Novartis Investigative Site
RECRUITING
Jerusalem
Novartis Investigative Site
RECRUITING
Nahariya
Novartis Investigative Site
RECRUITING
Petah Tikva
Novartis Investigative Site
RECRUITING
Ramat Gan
Novartis Investigative Site
RECRUITING
Tel Aviv
Italy
Novartis Investigative Site
RECRUITING
Ancona
Novartis Investigative Site
RECRUITING
Bergamo
Novartis Investigative Site
WITHDRAWN
Bologna
Novartis Investigative Site
RECRUITING
Brescia
Novartis Investigative Site
RECRUITING
Caserta
Novartis Investigative Site
RECRUITING
Cona
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
RECRUITING
Padova
Novartis Investigative Site
RECRUITING
Pordenone
Novartis Investigative Site
RECRUITING
Pozzilli
Netherlands
Novartis Investigative Site
RECRUITING
Amsterdam
Novartis Investigative Site
RECRUITING
Amsterdam
Novartis Investigative Site
RECRUITING
Nieuwegein
Novartis Investigative Site
RECRUITING
Rotterdam
Novartis Investigative Site
RECRUITING
Rotterdam
Portugal
Novartis Investigative Site
RECRUITING
Alcabideche
Novartis Investigative Site
RECRUITING
Braga
Novartis Investigative Site
RECRUITING
Coimbra
Novartis Investigative Site
RECRUITING
Vila Nova De Gaia
Spain
Novartis Investigative Site
RECRUITING
Cáceres
Novartis Investigative Site
RECRUITING
Córdoba
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
WITHDRAWN
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Salamanca
Novartis Investigative Site
RECRUITING
Valencia
Switzerland
Novartis Investigative Site
RECRUITING
Basel
Novartis Investigative Site
RECRUITING
Geneva
Novartis Investigative Site
RECRUITING
Lausanne
Novartis Investigative Site
RECRUITING
Lugano
Novartis Investigative Site
RECRUITING
Zurich
United Kingdom
Novartis Investigative Site
RECRUITING
Edinburgh
Novartis Investigative Site
RECRUITING
Leicester
Novartis Investigative Site
RECRUITING
Liverpool
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Londonderry
Novartis Investigative Site
RECRUITING
Manchester
Novartis Investigative Site
RECRUITING
Middlesbrough
Novartis Investigative Site
RECRUITING
Norwich
Novartis Investigative Site
RECRUITING
Portadown
Novartis Investigative Site
RECRUITING
Reading
Novartis Investigative Site
RECRUITING
Tyne And Wear
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2024-03-07
Estimated Completion Date: 2030-03-12
Participants
Target number of participants: 502
Treatments
Experimental: Pelacarsen (TQJ230) 80mg
Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously
Placebo_comparator: Matching placebo
Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals