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NCT06875973PHASE3Recruiting

Pelacarsen Roll-over Extension Program

Novartis Pharmaceuticals

Start Date

5/19/2025

Completion Date

12/8/2030

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).

Detailed Description

This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.

Eligibility Criteria

Age Range: 18 years to 100 years

Inclusion Criteria: * Participants who have provided informed consent prior to initiation of any study-specific activities/procedures. * Participants who have completed the parent study and received the assigned study treatment at the time of its completion Exclusion Criteria: * Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study * Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation * Participants who are receiving another investigational drug or device before the open-label treatment period * Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator Other protocol-defined inclusion/exclusion criteria may apply.

Interventions

DRUG

Pelacarsen (TQJ230)

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Conditions

Atherosclerotic Cardiovascular Disease

Locations

Parkway Medical Center

Birmingham, Alabama 35215

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

California Medical Research Associates Inc

Northridge, California 91324

United States

Stanford Health Care

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

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

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 South

Miami, Florida 33173

United States

A&A Research Group Inc

Miami, Florida 33186

United States

Inpatient Research Clinical LLC

Miami Lakes, Florida 33014

United States

Inpatient Research Clinical LLC

Miami Lakes, Florida 33014

United States

FXM Clin Res Miramar 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

Flourish Research

Winter Park, Florida 32789

United States

Flourish Research

Winter Park, Florida 32789

United States

Morehouse School Of Medicine

Atlanta, Georgia 30310

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

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

Ft. 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

Aa Mrc Mhs

Flint, Michigan 48503

United States

Aa Mrc Llc

Flint, Michigan 48504

United States

Elite Clinical Research

Jackson, Mississippi 39202

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

Richmond Hill, New York 11418

United States

Monroe Biomedical Research

Monroe, North Carolina 28112

United States

Alliance Medical Ministry

Raleigh, North Carolina 27610

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

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

Angiocardiac Care of Texas PA

Houston, Texas 77025

United States

Dallas Heart and Vascular Consultants PA

Houston, Texas 77084

United States

Dallas Heart and Vascular Consultants PA

Houston, Texas 77084

United States

Dallas Heart and Vascular Consultants PA

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

Javara Research

Alexandria, Virginia 22311

United States

Javara Research

Alexandria, Virginia 22311

United States

Javara Research

Alexandria, Virginia 22311

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

Vcu Health

Richmond, Virginia 23298

United States

University of Washington

Seattle, Washington 98195

United States

Advanced Clinical Research LLC

Bayamón, 00959

Puerto Rico

Dr Yolanda Figueroa Private Pr

Humacao, 00791

Puerto Rico

CAIMED Center

Ponce, 00716

Puerto Rico

Research and Cardiovascular Corp

Ponce, 00717-1322

Puerto Rico

Latin Clinical Trial Center Inc

San Juan, 00909

Puerto Rico

VA Caribbean Healthcare System

San Juan, 00921

Puerto Rico