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RecruitingPhase 2

A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Novartis Pharmaceuticals · NCT05646381

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
502
US sites recruiting
33
Study start
March 7, 2024
Record last updated
June 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Pelacarsen (TQJ230) 80mg; Matching placebo

Conditions: Aortic Stenosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

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

Recruiting US locations

  • Heart Center Research Llc

    Huntsville, AL 35801

    Site contact: Amy Williams · +1 256 519 8255 · awilliams@theheartcenter.md

  • Cardiovascular Res Found

    Beverly Hills, CA 90210

    Site contact: Juan Ramos · +1 310 278 3400 · juan.ramos@cvmg.com

  • National Heart Institute

    Beverly Hills, CA 90211

    Site contact: Maria Flores · +1 301 289 5221 · mflores@nationalheartinstitute.org

  • Flourish Clinical Resrch Covin

    Covina, CA 91723

    Site contact: Sarita Garcia · +1 714 299 2412 · sgarcia@flourishresearch.com

  • Valley Clinical Trials

    Northridge, CA 91325

    Site contact: Haydee Gutierrez · +1 818 280 4220 · haydee@valleyclinicaltrials.com

  • Stanford University Medical Center

    Palo Alto, CA 94304

    Site contact: Tamara Bazouzi · +1 650 736 7878 · bazouzit@stanford.edu

  • University Of California San Diego

    San Diego, CA 92103-8415

    Site contact: Ruby Swaim · +1 858 246 2510 · rswaim@health.ucsd.edu

  • UC San Francisco Medical Center

    San Francisco, CA 94143

    Site contact: Liliann Zou · +1 415 514 3156 · liliann.zou@ucsf.edu

  • Nova Clinical Research LLC

    Bradenton, FL 34209

    Site contact: Sade Andrews · +1 941 792 6564 · sade.andrews@novaclinicalresearch.com

  • Flourish Res Acq LLC North Miami

    Miami, FL 33138

    Site contact: Ashlee Sealy · asealy@flourishresearch.com

  • Inpatient Research Clinical LLC

    Miami Lakes, FL 33014

    Site contact: Dora Gutierrez · +1 786 502 4303 · dgutierrez@inpatientresearch.com

  • Midwest Heart and Vascular Spec

    Overland Park, KS 66211

    Site contact: Elizabeth Fulks · +1 913 253 3000 · Elizabeth.fulks@hcahealthcare.com

  • Tufts Medical Center

    Boston, MA 02111

    Site contact: Veronique Recile · +1 617 636 5897

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Victoria Viscosi · +1 813 943 3440 · vviscosi@mgh.harvard.edu

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Victoria Viscosi · vviscosi@mgh.harvard.edu

  • Brigham and Womens Hosp Harvard Med School

    Boston, MA 02115

    Site contact: Sam Wong · +1 617 347 8680 · swong1@bwh.harvard.edu

  • Brigham and Womens Hosp Harvard Med School

    Boston, MA 02115

    Site contact: Sam Wong · +1 617 525 1227 · swong1@bwh.harvard.edu

  • Henry Ford Hospital

    Detroit, MI 48202

    Site contact: Jodi Carter, BS, CCRP · +1 (313) 916-3613

  • Henry Ford Hospital

    Detroit, MI 48202

    Site contact: Jodi Carter · +1 313 590 2407 · jcarte23@hfhs.org

  • AA Medical Research Center

    Flint, MI 48504

    Site contact: Fayyaz Shah · +1 810 237 1125 · fshah@aamrc.net

  • William Beaumont Hospital

    Royal Oak, MI 48073-4192

    Site contact: Rachel Wylie · +1 248 551 4192 · rachel.wylie@corewellhealth.org

  • University Of Minnesota

    Minneapolis, MN 55455

    Site contact: Michelle Pitt · +1 612 624 4948 · henni032@umn.edu

  • Overlook Medical Center

    Summit, NJ 07901

    Site contact: Rosmery Montesino · +1 908 522 6279 · Rosmery.montesino@atlantichealth.org

  • Capital Cardiology Associates

    Albany, NY 12211

    Site contact: Shreya Shah · sshah@capitalcardiology.com

  • Icahn School of Med at Mt Sinai

    New York, NY 10029

    Site contact: Jay Krishna Katragadda · +1 212 659 9174 · jaykrishna.katragadda@mssm.edu

  • Strong Memorial Hospital

    Rochester, NY 14642

    Site contact: Ferogh Shakouri · +1 716 275 7753 · ferogh_shakouri@URMC.Rochester.edu

  • Wake Forest University Baptist Medical Center

    Winston-Salem, NC 27157

    Site contact: Donna Davis · donna.h.davis@advocatehealth.org

  • Lindner Ctr At The Christ Hosp

    Cincinnati, OH 45219

    Site contact: Meghan Grone · +1 513 585 1777 · Meghan.Grone@thechristhospital.com

  • Perelman School of Medicine

    Philadelphia, PA 19104

    Site contact: Manali Shah · manali.shah2@pennmedicine.upenn.edu

  • Texas Heart Institute

    Houston, TX 77030

    Site contact: Dominique Robertson · +1 832 355 8520 · dominique.robertson@bcm.edu

  • Orion Medical

    Houston, TX 77034

    Site contact: Lena Olivera Perez · lena.oliveraperez@usheartandvascular.com

  • Virginia Heart

    Falls Church, VA 22042

    Site contact: Oyinda Agbale · +1 703 766 5920 · oagbale@virginiaheart.com

  • Carient Heart and Vascular

    Manassas, VA 20109

    Site contact: Hameeda Tasneem · +1 70 333 58 750 · htasneem@carient.com

Study contacts (from the official record)

  • Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
  • Novartis Pharmaceuticals · +41613241111
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A Multicenter Trial Assessing the Impact of Lipoprotein(a)… (NCT05646381) | Bored Studies