RECRUITING

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

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Conditions

Aortic StenosisCardiovascularLipoprotein(a)Lp(a)Hyperlipoproteinemia(a)Calcific aortic valve stenosisTQJ230PelacarsenAortic valve stenosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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]

Quick Facts

Study Start:2024-03-07
Study Completion:2029-01-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05646381

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female ≥50 to \<80 years of age
  2. * Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
  3. * Mild or moderate calcific aortic valve stenosis
  4. * At the randomization visit, participant must be optimally treated for existing CV risk factors
  1. * Severe calcific aortic valve stenosis
  2. * Uncontrolled hypertension
  3. * History of malignancy of any organ system
  4. * History of hemorrhagic stroke or other major bleeding
  5. * Platelet count ≤ LLN
  6. * Active liver disease or hepatic dysfunction
  7. * Significant kidney disease
  8. * Pregnant or nursing women

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

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
Valley Clinical Trials
Northridge, California, 91325
United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434
United States
Advanced Research for Health Improvement LLC
Naples, Florida, 34102
United States
Midwest Heart and Vascular Spec
Overland Park, Kansas, 66211
United States
Massachusetts General Hospital Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Womens Hosp Harvard Med School .
Boston, Massachusetts, 02115
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
United States
Overlook Medical Center
Summit, New Jersey, 07901
United States
New York Presbyterian Hospital Weill Cornell Med Ctr
New York, New York, 10021
United States
Wake Forest University Baptist Medical Center Wake Forest
Winston-Salem, North Carolina, 27157
United States
Ohio State University Heart and Vascular Res Org
Columbus, Ohio, 43210
United States
Virginia Heart
Falls Church, Virginia, 22042
United States
Carient Heart and Vascular
Manassas, Virginia, 20109
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-07
Study Completion Date2029-01-03

Study Record Updates

Study Start Date2024-03-07
Study Completion Date2029-01-03

Terms related to this study

Keywords Provided by Researchers

  • Cardiovascular
  • Lipoprotein(a)
  • Lp(a)
  • Hyperlipoproteinemia(a)
  • Calcific aortic valve stenosis
  • TQJ230
  • Pelacarsen
  • Aortic valve stenosis
  • Aortic stenosis

Additional Relevant MeSH Terms

  • Aortic Stenosis