RecruitingPhase 3NCT06875973

Pelacarsen Roll-over Extension Program

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open-Label Pelacarsen in Participants With Elevated Lp(a) and Established ASCVD

Sponsor

Novartis Pharmaceuticals

Enrollment

599 participants

Start Date

May 19, 2025

Study Type

INTERVENTIONAL

Conditions

Atherosclerotic Cardiovascular Disease

Summary

This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Pelacarsen (TQJ230) for people with atherosclerotic cardiovascular disease. The study is currently recruiting participants at 97 locations. People eligible for this study include aged 18 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPelacarsen (TQJ230)

pelacarsen 80mg s.c. monthly

Locations(97)

Parkway Medical Center

Birmingham, Alabama, United States

Cardiology and Medicine Clinic PA

Little Rock, Arkansas, United States

National Heart Institute

Beverly Hills, California, United States

Hope Clinical Research

Canoga Park, California, United States

Valley Clinical Trials Inc

Covina, California, United States

NICRs Research Center

Garden Grove, California, United States

University of Calif Irvine Med Cntr

Irvine, California, United States

Long Beach Clinical Trials

Long Beach, California, United States

Angel City Research Inc

Los Angeles, California, United States

California Medical Research Associates Inc

Northridge, California, United States

Stanford Health Care

Stanford, California, United States

Excel Medical Clinical Trials LLC

Boca Raton, Florida, United States

C and A Clinical Trials

Cape Coral, Florida, United States

Proactive Clinical Research

Fort Lauderdale, Florida, United States

Proactive Clinical Research

Fort Lauderdale, Florida, United States

National Research Institute

Hialeah, Florida, United States

Sister Life Research Inc

Hialeah, Florida, United States

Zenith Clinical Research

Hollywood, Florida, United States

Columbus Clinical Services LLC

Miami, Florida, United States

Finlay Medical Research

Miami, Florida, United States

Infinite Clinical Research

Miami, Florida, United States

International Research Associates LLC

Miami, Florida, United States

Baptist Health South

Miami, Florida, United States

A&A Research Group Inc

Miami, Florida, United States

Inpatient Research Clinical LLC

Miami Lakes, Florida, United States

Inpatient Research Clinical LLC

Miami Lakes, Florida, United States

FXM Clin Res Miramar LLC

Miramar, Florida, United States

CTMD Research

Palm Springs, Florida, United States

DBC Research USA

Pembroke Pines, Florida, United States

New Tampa Health

Tampa, Florida, United States

James A Haley Veterans Hospital

Tampa, Florida, United States

Cardiology Partners Clinical Research Institute

Wellington, Florida, United States

Flourish Research

Winter Park, Florida, United States

Flourish Research

Winter Park, Florida, United States

Morehouse School Of Medicine

Atlanta, Georgia, United States

Atlanta Heart Specialists LLC

Tucker, Georgia, United States

Synexus Clinical Research US Inc

Chicago, Illinois, United States

Chicago Clinical Research Inst

Chicago, Illinois, United States

Cardiovascular Associates Research

Covington, Louisiana, United States

Omega Clinical Research

Metairie, Louisiana, United States

CV Ins of the South

Opelousas, Louisiana, United States

Monroe Research Llc

West Monroe, Louisiana, United States

Southern Clin Research Clinic

Zachary, Louisiana, United States

Sinai Ct for Throm Res and Drug Dev

Baltimore, Maryland, United States

Ascension Saint Agnes Heart Care

Baltimore, Maryland, United States

Johns Hopkins Univ School of Med

Baltimore, Maryland, United States

Metropolitan Cardiovascular Consultants Llc

Beltsville, Maryland, United States

Johns Hopkins University

Columbia, Maryland, United States

Anderson Medical Research

Ft. Washington, Maryland, United States

Capitol Cardiology Associates

Lanham, Maryland, United States

MD Medical Research

Oxon Hill, Maryland, United States

Henry Ford Hospital

Detroit, Michigan, United States

Aa Mrc Mhs

Flint, Michigan, United States

Aa Mrc Llc

Flint, Michigan, United States

Elite Clinical Research

Jackson, Mississippi, United States

Stern Cardiovascular Foundation Inc

Southaven, Mississippi, United States

Las Vegas Endocrinology

Henderson, Nevada, United States

AB Clinical Trials

Las Vegas, Nevada, United States

Clinical Research of South Nevada

Las Vegas, Nevada, United States

Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Overlook Medical Center

Summit, New Jersey, United States

Jamaica Hospital Medical Center

Richmond Hill, New York, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Alliance Medical Ministry

Raleigh, North Carolina, United States

NexGen Research

Lima, Ohio, United States

Care Access Research

Easton, Pennsylvania, United States

TCV Clinical Studies

Linwood, Pennsylvania, United States

Apex Cardiology Research Associates of Jackson

Jackson, Tennessee, United States

Plano Primary Care Clinic

Allen, Texas, United States

Pharma Tex Research

Amarillo, Texas, United States

North Hills Medical Research Inc

Bedford, Texas, United States

SW Family Medicine Associates

Dallas, Texas, United States

David Turbay MD PLLC

El Paso, Texas, United States

Angiocardiac Care of Texas PA

Houston, Texas, United States

Dallas Heart and Vascular Consultants PA

Houston, Texas, United States

Dallas Heart and Vascular Consultants PA

Houston, Texas, United States

Dallas Heart and Vascular Consultants PA

Houston, Texas, United States

Epic Clinical Research

Lewisville, Texas, United States

The Heart Institute of East Texas

Lufkin, Texas, United States

Discovery Clinical Trials

Pflugerville, Texas, United States

University of Texas Health Science Ctr

San Antonio, Texas, United States

Clinical Trials of Texas

San Antonio, Texas, United States

Javara Research

Alexandria, Virginia, United States

Javara Research

Alexandria, Virginia, United States

Javara Research

Alexandria, Virginia, United States

Javara Research

Alexandria, Virginia, United States

Virginia Heart

Falls Church, Virginia, United States

Heart Care Associates P C

Hopewell, Virginia, United States

Dominion Medical Associates

Richmond, Virginia, United States

Vcu Health

Richmond, Virginia, United States

University of Washington

Seattle, Washington, United States

Advanced Clinical Research LLC

Bayamón, Puerto Rico

Dr Yolanda Figueroa Private Pr

Humacao, Puerto Rico

CAIMED Center

Ponce, Puerto Rico

Research and Cardiovascular Corp

Ponce, Puerto Rico

Latin Clinical Trial Center Inc

San Juan, Puerto Rico

VA Caribbean Healthcare System

San Juan, Puerto Rico

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06875973

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