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
Advanced Clinical Research LLC
Recruiting
Bayamon,00959,Puerto Rico
Vilma Perez
Angel Comulada
Latin Clinical Trial Center Inc
Recruiting
San Juan,00909,Puerto Rico
Alex Gonzalez Bossolo
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
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Ponce,00717-1322,Puerto Rico
Jose B Vazquez-Tanus
AB Clinical Trials
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Las Vegas,Nevada,89119,United States
Atoya Adams
TCV Clinical Studies
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Linwood,Pennsylvania,19061,United States
Jocelynn Vega
Edward Stankiewicz
Discovery Clinical Trials
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Pflugerville,Texas,78660-3015,United States
Brian K MacGillivray
Velocity Clinical Trials
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Los Angeles,California,90057,United States
Stanley Hsin-Wei Hsia
Aa Mrc Llc
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Flint,Michigan,48504,United States
Rania Takriti
Ahmed Arif
Cardiology Partners Clinical Research Institute
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Wellington,Florida,33449,United States
Duccio Baldari
Javara Research
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Alexandria,Virginia,22311,United States
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
Kathryn McSpadden
Columbus Clinical Services LLC
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Miami,Florida,33125,United States
Sara Llerena
C and A Clinical Trials
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Cape Coral,Florida,33990,United States
Juan Antonio Carmona Herrera
Arturo Alvarez
University At Buffalo
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Buffalo,New York,14203,United States
Thomas Cimato
Flourish Research
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Grandwood Park,Illinois,60031,United States
Sara Collins
Alfonso Gonzales-Rodriguez
Angelica Perez
Daniel Stokes
Synexus Clinical Research Advantage
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Birmingham,Alabama,35211,United States
William Kirby
TBC Research LLC
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Tamarac,Florida,33321,United States
Barry Streit
Ricardo Zambrano
Grady Health System
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Atlanta,Georgia,30303,United States
Jalal Ghali
NexGen Research
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Lima,Ohio,45801,United States
Nonso Ezema
Biopharma Informatic LLC
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Houston,Texas,77084,United States
Imran Afridi
Shah Mohammed
Syed Humayun Naqvi
Christian Assad-Kottner
Clarisa Garza
Long Beach Clinical Trials
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Long Beach,California,90806,United States
Suzanne Fussell
MD Medical Research
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Oxon Hill,Maryland,20745,United States
John Hakim
Heart Care Associates P C
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Hopewell,Virginia,23860,United States
Kamlesh Dave
SW Family Medicine Associates
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Dallas,Texas,75235,United States
Chrisette Dharma
David Turbay MD PLLC
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El Paso,Texas,79905,United States
David Turbay
Sugar Lakes Family Practice
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Sugar Land,Texas,77479,United States
John Vanderzyl
National Research Institute
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Hialeah,Florida,33013,United States
Raul Alonso
Idania Cruz
Luis Cabrera Haber
Clinical Research of South Nevada
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Las Vegas,Nevada,89121,United States
Roger Estevez
Synexus Clinical Research US Inc
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Chicago,Illinois,60602,United States
Joseph Newberg
Baptist Health Medical Group
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Miami,Florida,33173,United States
Adedapo Iluyomade
Inpatient Research Clinical LLC
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Miami Lakes,Florida,33014,United States
Alexis Gutierrez
Monroe Biomedical Research
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Monroe,North Carolina,28112,United States
Awawu Igbinadolor
Southern Clin Research Clinic
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Zachary,Louisiana,70791,United States
Ernest Thompson
Tammy Dours
Cardiology and Medicine Clinic PA
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Little Rock,Arkansas,72204,United States
Joe L Hargrove
Metropolitan Cardiovascular Consultants Llc
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Beltsville,Maryland,20705,United States
Ayim Akyea-Djamson
The Stern Cardiovascular Foundation
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Germantown,Tennessee,38138,United States
Frank Augustus McGrew
Acclaim Clinical Research
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San Diego,California,92120,United States
John Beckes
Elite Clinical Research LLC
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Jackson,Mississippi,39211,United States
Honey East
Proactive Clinical Research
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Fort Lauderdale,Florida,33308,United States
David Mishkin
Juan Garcia
Maria Coimbra
Jamaica Hospital Medical Center
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Jamaica,New York,11418,United States
David Coven
Cambridge Medical Trials
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Alexandria,Louisiana,71301,United States
Naseem A Jaffrani
Parkway Medical Center
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Birmingham,Alabama,35215,United States
James Sullivan
Virginia Commonwealth University
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Richmond,Virginia,23298-0111,United States
Anurag Mehta
Joshua West
Care Access Research
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Easton,Pennsylvania,18045,United States
Eromonsele Idahosa
Jimmy Alele
Melissa Sexton
Rebecca Larimore
Henry Ford Hospital
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Detroit,Michigan,48202,United States
Sachin Parikh
Chicago Clinical Research Inst
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Chicago,Illinois,60607,United States
Dennis Levinson
Virginia Heart
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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
Robert Wood Johnson Medical School
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New Brunswick,New Jersey,08901,United States
Heena Gandhi
Tudor D Vagaonescu
Johns Hopkins University
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Columbia,Maryland,21044,United States
Daniel Kim
Clinical Trials of Florida
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Miami,Florida,33186,United States
Mark Rosenthal
Velocity Clin Research Springdale
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Cincinnati,Ohio,45246,United States
Douglas K Logan
Morehouse School Of Medicine
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Atlanta,Georgia,30310,United States
Priscilla Igho-Pemu
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
Stern Cardiovascular Foundation Inc
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Southaven,Mississippi,38671,United States
Dharmesh Patel
Finlay Medical Research
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Miami,Florida,33126,United States
Lilia Rodriguez-Ables
New Tampa Health
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Tampa,Florida,33603,United States
Esther Echevarria-Crespo
Loraine Gonzalez
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
Sinai Ct for Throm Res and Drug Dev
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Baltimore,Maryland,21209,United States
Paul Gurbel
National Heart Institute
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Beverly Hills,California,90211,United States
Norman Lepor
Eminat LLC
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Miramar,Florida,33027,United States
Yaneth Trujillo
Plano Primary Care Clinic
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Allen,Texas,75002-3688,United States
Muhammad Moin Farooqi
Ventura Heart Institute
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Thousand Oaks,California,91360,United States
Irving Kent Loh
Rocio Ma
Omega Clinical Research
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Metairie,Louisiana,70006,United States
Tuan-Huy Tran
Optimal Research LLC
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Huntsville,Alabama,35802,United States
Jared-Robert Blake
Randle T Middleton
Ascension Saint Agnes Heart Care
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Baltimore,Maryland,21229,United States
Martin Albornoz
Flint Clinical Research
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Flint,Michigan,48503,United States
Khalid Ahmed
University of Washington
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Seattle,Washington,98195,United States
Francis Kim
Lily Zavala
Overlook Medical Center
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Summit,New Jersey,07901,United States
Robert Fishberg
Dominion Medical Associates
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Richmond,Virginia,23219,United States
Richard A Jackson
Excel Medical Clinical Trials LLC
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Boca Raton,Florida,33434,United States
David Funt
Capitol Cardiology Associates
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Lanham,Maryland,20706,United States
Vineet Venugopal
CTMD Research
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Palm Springs,Florida,33406,United States
Luis Castillo
Hometown Urgent Care and Research
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Columbus,Ohio,43214,United States
Steve Choi
Las Vegas Endocrinology
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Henderson,Nevada,89074,United States
Quang Nguyen
Atlanta Heart Specialists LLC
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Tucker,Georgia,30084,United States
David Suh
Pharma Tex Research
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Amarillo,Texas,79106,United States
David Brabham
Javara Research
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San Marcos,Texas,78666,United States
Alan Lee
Wake Forest Health Network LLC
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Asheboro,North Carolina,27203,United States
Robert Dough
Stacy Jones
Johns Hopkins Univ School of Med
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Baltimore,Maryland,21287,United States
Thorsten Leucker
International Research Associates, LLC
Recruiting
Miami,Florida,33156,United States
Cristian Breton
Juan J Calderon
Angel City Research Inc
Recruiting
Los Angeles,California,90026,United States
Felix Sigal
Joanna Cuevas
James A Haley Veterans Hospital
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Tampa,Florida,33612,United States
David Whitaker
Anderson Medical Research
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Fort Washington,Maryland,20744,United States
Felton Anderson
Epic Clinical Research
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Lewisville,Texas,75057,United States
Manjoo Sharma
NICRs Research Center
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Garden Grove,California,92844,United States
Mallu Reddy
Vincent Ribaya
DBC Research USA
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Pembroke Pines,Florida,33029,United States
Alvaro Murcia
North Hills Medical Research Inc
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Bedford,Texas,76021,United States
John D Gabriel
Zenith Clinical Research
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Hollywood,Florida,33021,United States
Moises Issa
CV Ins of the South
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Opelousas,Louisiana,70570,United States
siby george ayalloore
Synexus
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Glendale,Arizona,85306,United States
Elysa Shaw
Tahmina Stanikzai
Fam Medical Specialists Of Fl Plc
Recruiting
Plant City,Florida,33563,United States
Michael Gimness
Ctr For Clin Rsrch And Innovation
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Spring,Texas,77389,United States
Jorge Guerrero
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