ACTIVE_NOT_RECRUITING

Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD

Talk to us

Conditions

Elevated Lp(a) and Established Atherosclerotic Cardiovascular DiseaseElevated Lp(a)Cardiovascular diseasePelacarsen (TQJ230)

Quick Navigation

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

Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk.

Official Title

A Randomized Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Pelacarsen (TQJ230) in US Black/African American & Hispanic Patient Populations With Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

Quick Facts

Study Start:2024-04-24
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06267560

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:18 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 US Black/African American and US Hispanic participants 18 to ≤ 80 years of age
  2. * Lp(a) ≥ 125 nmol/L at the screening visit, measured at the Central laboratory
  3. * On Standard of Care (SoC) therapy for risk factors other than Lp(a), including LDL-C (LDL-C lowering therapy dose stable for at least 30 days), elevated blood pressure and diabetes, at the randomization visit according to local practice/guidelines.
  4. * Established ASCVD disease defined as documented:
  5. * Coronary heart disease (CHD) and/or
  6. * Cerebrovascular disease (CVD) and/or
  7. * Peripheral arterial disease (PAD):
  1. * Uncontrolled hypertension
  2. * Heart failure New York Heart Association (NYHA) class IV
  3. * History of malignancy of any organ system
  4. * History of hemorrhagic stroke or other major bleeding
  5. * Platelet count \<140,000 per mm3
  6. * Active liver disease or hepatic dysfunction
  7. * Significant kidney disease
  8. * Pregnant or nursing women

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Synexus Clinical Research Advantage
Birmingham, Alabama, 35211
United States
Parkway Medical Center
Birmingham, Alabama, 35215
United States
Optimal Research LLC
Huntsville, Alabama, 35802
United States
Synexus
Glendale, Arizona, 85306
United States
Cardiology and Medicine Clinic PA
Little Rock, Arkansas, 72204
United States
National Heart Institute
Beverly Hills, California, 90211
United States
Hope Clinical Research
Canoga Park, California, 91303
United States
Valley Clinical Trials Inc
Covina, California, 91723
United States
NICRs Research Center
Garden Grove, California, 92844
United States
University of Calif Irvine Med Cntr
Irvine, California, 92660
United States
Long Beach Clinical Trials
Long Beach, California, 90806
United States
Angel City Research Inc
Los Angeles, California, 90026
United States
Velocity Clinical Trials
Los Angeles, California, 90057
United States
California Medical Research Associates Inc
Northridge, California, 91324
United States
Acclaim Clinical Research
San Diego, California, 92120
United States
Stanford University Medical Center
Stanford, California, 94305
United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434
United States
C and A Clinical Trials
Cape Coral, Florida, 33990
United States
Proactive Clinical Research
Fort Lauderdale, Florida, 33308
United States
National Research Institute
Hialeah, Florida, 33013
United States
Sister Life Research Inc
Hialeah, Florida, 33013
United States
Zenith Clinical Research
Hollywood, Florida, 33021
United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014
United States
Columbus Clinical Services LLC
Miami, Florida, 33125
United States
Finlay Medical Research
Miami, Florida, 33126
United States
Infinite Clinical Research
Miami, Florida, 33133
United States
International Research Associates, LLC
Miami, Florida, 33156
United States
Baptist Health Medical Group
Miami, Florida, 33173
United States
A&A Research Group Inc
Miami, Florida, 33186
United States
Clinical Trials of Florida
Miami, Florida, 33186
United States
Eminat LLC
Miramar, Florida, 33027
United States
CTMD Research
Palm Springs, Florida, 33406
United States
DBC Research USA
Pembroke Pines, Florida, 33029
United States
New Tampa Health
Tampa, Florida, 33603
United States
James A Haley Veterans Hospital
Tampa, Florida, 33612
United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449
United States
Grady Health System
Atlanta, Georgia, 30303
United States
Morehouse School Of Medicine
Atlanta, Georgia, 30310
United States
Comprehensive Neurosciences Inc
Atlanta, Georgia, 30328
United States
Atlanta Heart Specialists LLC
Tucker, Georgia, 30084
United States
Synexus Clinical Research US Inc
Chicago, Illinois, 60602
United States
Chicago Clinical Research Inst
Chicago, Illinois, 60607
United States
Flourish Research
Grandwood Park, Illinois, 60031
United States
Cardiovascular Associates Research
Covington, Louisiana, 70433
United States
Omega Clinical Research
Metairie, Louisiana, 70006
United States
CV Ins of the South
Opelousas, Louisiana, 70570
United States
Monroe Research Llc
West Monroe, Louisiana, 71291
United States
Southern Clin Research Clinic
Zachary, Louisiana, 70791
United States
Sinai Ct for Throm Res and Drug Dev
Baltimore, Maryland, 21209
United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229
United States
Johns Hopkins Univ School of Med
Baltimore, Maryland, 21287
United States
Metropolitan Cardiovascular Consultants Llc
Beltsville, Maryland, 20705
United States
Johns Hopkins University
Columbia, Maryland, 21044
United States
Anderson Medical Research
Fort Washington, Maryland, 20744
United States
Capitol Cardiology Associates
Lanham, Maryland, 20706
United States
MD Medical Research
Oxon Hill, Maryland, 20745
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Flint Clinical Research
Flint, Michigan, 48503
United States
Aa Mrc Llc
Flint, Michigan, 48504
United States
Elite Clinical Research LLC
Jackson, Mississippi, 39211
United States
University of Mississippi Med Ctr
Jackson, Mississippi, 39216
United States
Stern Cardiovascular Foundation Inc
Southaven, Mississippi, 38671
United States
Las Vegas Endocrinology
Henderson, Nevada, 89074
United States
AB Clinical Trials
Las Vegas, Nevada, 89119
United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121
United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
United States
Overlook Medical Center
Summit, New Jersey, 07901
United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418
United States
Monroe Biomedical Research
Monroe, North Carolina, 28112
United States
Alliance Medical Ministry
Raleigh, North Carolina, 27610
United States
Velocity Clin Research Springdale
Cincinnati, Ohio, 45246
United States
Hometown Urgent Care and Research
Columbus, Ohio, 43214
United States
NexGen Research
Lima, Ohio, 45801
United States
Care Access Research
Easton, Pennsylvania, 18045
United States
TCV Clinical Studies
Linwood, Pennsylvania, 19061
United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
United States
Apex Cardiology Research Associates of Jackson
Jackson, Tennessee, 38301
United States
Plano Primary Care Clinic
Allen, Texas, 75002-3688
United States
Pharma Tex Research
Amarillo, Texas, 79106
United States
North Hills Medical Research Inc
Bedford, Texas, 76021
United States
SW Family Medicine Associates
Dallas, Texas, 75235
United States
David Turbay MD PLLC
El Paso, Texas, 79905
United States
Ctr for Clin Rsch and Innovatn
Houston, Texas, 77008
United States
Angiocardiac Care of Texas PA
Houston, Texas, 77025
United States
Biopharma Informatic LLC
Houston, Texas, 77084
United States
Epic Clinical Research
Lewisville, Texas, 75057
United States
The Heart Institute of East Texas
Lufkin, Texas, 75904
United States
Discovery Clinical Trials
Pflugerville, Texas, 78660-3015
United States
University of Texas Health Science Ctr
San Antonio, Texas, 78229-3900
United States
Clinical Trials of Texas
San Antonio, Texas, 78229
United States
Sugar Lakes Family Practice
Sugar Land, Texas, 77479
United States
Javara Research
Alexandria, Virginia, 22311
United States
Virginia Heart
Falls Church, Virginia, 22042
United States
Heart Care Associates P C
Hopewell, Virginia, 23860
United States
Dominion Medical Associates
Richmond, Virginia, 23219
United States
Virginia Commonwealth University
Richmond, Virginia, 23298-0111
United States
University of Washington
Seattle, Washington, 98195
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 Date2024-04-24
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-04-24
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • Elevated Lp(a)
  • Cardiovascular disease
  • Pelacarsen (TQJ230)

Additional Relevant MeSH Terms

  • Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease