Study 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. CTQJ230A12303 is a randomized, double-blind, placebo-controlled, multi-center, Phase IIIb study to evaluate the efficacy ( measured by reduction of the Lp(a) levels) and safety of pelacarsen (TQJ230) 80mg s.c. QM compared to placebo in US Black/African American and US Hispanic participants, with established atherosclerotic cardiovascular disease (ASCVD) as evidenced by history of coronary heart disease, cerebrovascular disease or symptomatic peripheral artery disease (PAD) and elevated levels of Lp(a).
Interventions
Placebo
TQJ230
Eligibility Criteria
Inclusion Criteria:
* Male and female US Black/African American and US Hispanic participants 18 to ≤ 80 years of age
* Lp(a) ≥ 125 nmol/L at the screening visit, measured at the Central laboratory
* 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.
* Established ASCVD disease defined as documented:
* Coronary heart disease (CHD) and/or
* Cerebrovascular disease (CVD) and/or
* Peripheral arterial disease (PAD):
Exclusion Criteria:
* Uncontrolled hypertension
* Heart failure New York Heart Association (NYHA) class IV
* History of malignancy of any organ system
* History of hemorrhagic stroke or other major bleeding
* Platelet count \<140,000 per mm3
* Active liver disease or hepatic dysfunction
* Significant kidney disease
* Pregnant or nursing women
Latin Clinical Trial Center Inc
Recruiting
San Juan,00909,Puerto Rico
Alex Gonzalez Bossolo
Advanced Clinical Research LLC
Recruiting
Bayamon,00959,Puerto Rico
Vilma Perez
Angel Comulada
Dr Yolanda Figueroa Private Pr
Recruiting
Humacao,00791,Puerto Rico
Yolanda Figueroa
VA Caribbean Healthcare System
Recruiting
San Juan,00921,Puerto Rico
Luis Rodriguez-Ospina
CAIMED Center
Recruiting
Ponce,00716,Puerto Rico
Elizabeth A. Barranco
Advanced Medical Research Center
Recruiting
San Juan,00926,Puerto Rico
Orvil F Martinez Rivera
Research and Cardiovascular Corp
Recruiting
Ponce,00717-1322,Puerto Rico
Jose B Vazquez-Tanus
Ctr For Clin Rsrch And Innovation
Recruiting
Spring,Texas,77389,United States
Jorge Guerrero
MD Medical Research
Recruiting
Oxon Hill,Maryland,20745,United States
John Hakim
Ventura Heart Institute
Recruiting
Thousand Oaks,California,91360,United States
Rocio Ma
Irving Kent Loh
NexGen Research
Recruiting
Lima,Ohio,45801,United States
Nonso Ezema
Atlanta Heart Specialists LLC
Recruiting
Tucker,Georgia,30084,United States
David Suh
SW Family Medicine Associates
Recruiting
Dallas,Texas,75235,United States
Chrisette Dharma
International Research Associates, LLC
Recruiting
Miami,Florida,33156,United States
Cristian Breton
Juan J Calderon
Zenith Clinical Research
Recruiting
Hollywood,Florida,33021,United States
Moises Issa
David Turbay MD PLLC
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El Paso,Texas,79905,United States
David Turbay
Omega Clinical Research
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Metairie,Louisiana,70006,United States
Tuan-Huy Tran
Synexus
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Glendale,Arizona,85306,United States
Tahmina Stanikzai
Elysa Shaw
Javara Research
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Alexandria,Virginia,22311,United States
Kathryn McSpadden
Aslam Khan
Monique Langston
Benjamin Marcum
Ronald M Pucillo
Chelsi Holliday
Aimee Kaczorowsi
Sangeeta Wagner
Gabriela Obeidat
Amara Akujieze
Scott Kahney
Habib Chotani
Amine Segueni
Stacy Jones
Jason Elenberger
Amy Reyna
Clinical Research of South Nevada
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Las Vegas,Nevada,89121,United States
Roger Estevez
AB Clinical Trials
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Las Vegas,Nevada,89119,United States
Atoya Adams
Discovery Clinical Trials
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Pflugerville,Texas,78660-3015,United States
Brian K MacGillivray
Metropolitan Cardiovascular Consultants Llc
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Beltsville,Maryland,20705,United States
Ayim Akyea-Djamson
Velocity Clinical Trials
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Los Angeles,California,90057,United States
Stanley Hsin-Wei Hsia
Monroe Biomedical Research
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Monroe,North Carolina,28112,United States
Awawu Igbinadolor
James A Haley Veterans Hospital
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Tampa,Florida,33612,United States
David Whitaker
Elite Clinical Research LLC
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Jackson,Mississippi,39211,United States
Honey East
Sister Life Research Inc
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Hialeah,Florida,33013,United States
Idania Cruz
Raul Alonso
Luis Cabrera Haber
C and A Clinical Trials
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Cape Coral,Florida,33990,United States
Juan Antonio Carmona Herrera
Arturo Alvarez
The Stern Cardiovascular Foundation
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Germantown,Tennessee,38138,United States
Frank Augustus McGrew
Flourish Research
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Grandwood Park,Illinois,60031,United States
Angelica Perez
Daniel Stokes
Sara Collins
Alfonso Gonzales-Rodriguez
Synexus Clinical Research Advantage
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Birmingham,Alabama,35211,United States
William Kirby
CTMD Research
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Palm Springs,Florida,33406,United States
Luis Castillo
Grady Health System
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Atlanta,Georgia,30303,United States
Jalal Ghali
Biopharma Informatic LLC
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Houston,Texas,77084,United States
Imran Afridi
Shah Mohammed
Syed Humayun Naqvi
Christian Assad-Kottner
Clarisa Garza
Ascension Saint Agnes Heart Care
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Baltimore,Maryland,21229,United States
Martin Albornoz
Long Beach Clinical Trials
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Long Beach,California,90806,United States
Suzanne Fussell
Heart Care Associates P C
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Hopewell,Virginia,23860,United States
Kamlesh Dave
Jamaica Hospital Medical Center
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Jamaica,New York,11418,United States
David Coven
Sugar Lakes Family Practice
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Sugar Land,Texas,77479,United States
John Vanderzyl
Henry Ford Hospital
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Detroit,Michigan,48202,United States
Sachin Parikh
Care Access Research
Recruiting
Easton,Pennsylvania,18045,United States
Eromonsele Idahosa
Jimmy Alele
Melissa Sexton
Rebecca Larimore
Robert Wood Johnson Medical School
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New Brunswick,New Jersey,08901,United States
Heena Gandhi
Tudor D Vagaonescu
Inpatient Research Clinical LLC
Recruiting
Miami Lakes,Florida,33014,United States
Alexis Gutierrez
CV Ins of the South
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Opelousas,Louisiana,70570,United States
siby george ayalloore
Cardiology and Medicine Clinic PA
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Little Rock,Arkansas,72204,United States
Joe L Hargrove
Johns Hopkins University
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Columbia,Maryland,21044,United States
Daniel Kim
Velocity Clin Research Springdale
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Cincinnati,Ohio,45246,United States
Douglas K Logan
Stern Cardiovascular Foundation Inc
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Southaven,Mississippi,38671,United States
Dharmesh Patel
Proactive Clinical Research
Recruiting
Fort Lauderdale,Florida,33308,United States
David Mishkin
Juan Garcia
Maria Coimbra
Parkway Medical Center
Recruiting
Birmingham,Alabama,35215,United States
James Sullivan
Virginia Commonwealth University
Recruiting
Richmond,Virginia,23298-0111,United States
Anurag Mehta
Joshua West
Fam Medical Specialists Of Fl Plc
Recruiting
Plant City,Florida,33563,United States
Michael Gimness
Synexus Clinical Research US Inc
Recruiting
Chicago,Illinois,60602,United States
Joseph Newberg
Virginia Heart
Recruiting
Falls Church,Virginia,22042,United States
Tariq Haddad
Valley Clinical Trials Inc
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Covina,California,91723,United States
Fahed Bitar
Mannie Lyons
Baptist Health Medical Group
Recruiting
Miami,Florida,33173,United States
Adedapo Iluyomade
Cardiology Partners Clinical Research Institute
Recruiting
Wellington,Florida,33449,United States
Duccio Baldari
Apex Cardiology Research Associates of Jackson
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Jackson,Tennessee,38301,United States
Mohsin Alhaddad
Clinical Trials of Texas
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San Antonio,Texas,78229,United States
Douglas Denham
Columbus Clinical Services LLC
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Miami,Florida,33125,United States
Sara Llerena
Plano Primary Care Clinic
Recruiting
Allen,Texas,75002-3688,United States
Muhammad Moin Farooqi
TBC Research LLC
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Tamarac,Florida,33321,United States
Barry Streit
Ricardo Zambrano
Cardiovascular Associates Research
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Covington,Louisiana,70433,United States
Dale Presser
American Institute of Research
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Los Angeles,California,90017,United States
Anil Mohin
Flint Clinical Research
Recruiting
Flint,Michigan,48503,United States
Khalid Ahmed
Southern Clin Research Clinic
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Zachary,Louisiana,70791,United States
Ernest Thompson
Tammy Dours
National Heart Institute
Recruiting
Beverly Hills,California,90211,United States
Norman Lepor
Overlook Medical Center
Recruiting
Summit,New Jersey,07901,United States
Robert Fishberg
Eminat LLC
Recruiting
Miramar,Florida,33027,United States
Yaneth Trujillo
Hometown Urgent Care and Research
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Columbus,Ohio,43214,United States
Steve Choi
Capitol Cardiology Associates
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Lanham,Maryland,20706,United States
Vineet Venugopal
Acclaim Clinical Research
Recruiting
San Diego,California,92120,United States
John Beckes
Cambridge Medical Trials
Recruiting
Alexandria,Louisiana,71301,United States
Naseem A Jaffrani
Optimal Research LLC
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Huntsville,Alabama,35802,United States
Jared-Robert Blake
Randle T Middleton
Las Vegas Endocrinology
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Henderson,Nevada,89074,United States
Quang Nguyen
University of Washington
Recruiting
Seattle,Washington,98195,United States
Francis Kim
Lily Zavala
Wake Forest Health Network LLC
Recruiting
Asheboro,North Carolina,27203,United States
Robert Dough
Stacy Jones
Johns Hopkins Univ School of Med
Recruiting
Baltimore,Maryland,21287,United States
Thorsten Leucker
Chicago Clinical Research Inst
Recruiting
Chicago,Illinois,60607,United States
Dennis Levinson
Dominion Medical Associates
Recruiting
Richmond,Virginia,23219,United States
Richard A Jackson
Excel Medical Clinical Trials LLC
Recruiting
Boca Raton,Florida,33434,United States
David Funt
Clinical Trials of Florida
Recruiting
Miami,Florida,33186,United States
Mark Rosenthal
Morehouse School Of Medicine
Recruiting
Atlanta,Georgia,30310,United States
Priscilla Igho-Pemu
Pharma Tex Research
Recruiting
Amarillo,Texas,79106,United States
David Brabham
Javara Research
Recruiting
San Marcos,Texas,78666,United States
Alan Lee
North Hills Medical Research Inc
Recruiting
Bedford,Texas,76021,United States
John D Gabriel
Finlay Medical Research
Recruiting
Miami,Florida,33126,United States
Lilia Rodriguez-Ables
Angel City Research Inc
Recruiting
Los Angeles,California,90026,United States
Felix Sigal
Joanna Cuevas
New Tampa Health
Recruiting
Tampa,Florida,33603,United States
Esther Echevarria-Crespo
Loraine Gonzalez
Anderson Medical Research
Recruiting
Fort Washington,Maryland,20744,United States
Felton Anderson
Epic Clinical Research
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Lewisville,Texas,75057,United States
Manjoo Sharma
TCV Clinical Studies
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Linwood,Pennsylvania,19061,United States
Edward Stankiewicz
Jocelynn Vega
Aa Mrc Llc
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Flint,Michigan,48504,United States
Ahmed Arif
Rania Takriti
Sinai Ct for Throm Res and Drug Dev
Recruiting
Baltimore,Maryland,21209,United States
Paul Gurbel
NICRs Research Center
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Garden Grove,California,92844,United States
Mallu Reddy
Vincent Ribaya
University At Buffalo
Recruiting
Buffalo,New York,14203,United States
Thomas Cimato
DBC Research USA
Recruiting
Pembroke Pines,Florida,33029,United States
Alvaro Murcia
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