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
CAIMED Center
Recruiting
Ponce,00716,Puerto Rico
Elizabeth A. Barranco
VA Caribbean Healthcare System
Recruiting
San Juan,00921,Puerto Rico
Luis Rodriguez-Ospina
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
Advanced Clinical Research LLC
Recruiting
Bayamon,00959,Puerto Rico
Angel Comulada
Vilma Perez
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
Clinical Trials of Texas
Recruiting
San Antonio,Texas,78229,United States
Douglas Denham
Care Access Research
Recruiting
Easton,Pennsylvania,18045,United States
Jimmy Alele
Melissa Sexton
Rebecca Larimore
Eromonsele Idahosa
Flourish Research
Recruiting
Grandwood Park,Illinois,60031,United States
Daniel Stokes
Sara Collins
Alfonso Gonzales-Rodriguez
Angelica Perez
Inpatient Research Clinical LLC
Recruiting
Miami Lakes,Florida,33014,United States
Alexis Gutierrez
Henry Ford Hospital
Recruiting
Detroit,Michigan,48202,United States
Sachin Parikh
National Research Institute
Recruiting
Hialeah,Florida,33013,United States
Raul Alonso
Luis Cabrera Haber
Idania Cruz
Cardiology and Medicine Clinic PA
Recruiting
Little Rock,Arkansas,72204,United States
Joe L Hargrove
AB Clinical Trials
Recruiting
Las Vegas,Nevada,89119,United States
Atoya Adams
Robert Wood Johnson Medical School
Recruiting
New Brunswick,New Jersey,08901,United States
Tudor D Vagaonescu
Heena Gandhi
Fam Medical Specialists Of Fl Plc
Recruiting
Plant City,Florida,33563,United States
Michael Gimness
Javara Research
Recruiting
Alexandria,Virginia,22311,United States
Chelsi Holliday
Aimee Kaczorowsi
Sangeeta Wagner
Gabriela Obeidat
Amara Akujieze
Scott Kahney
Habib Chotani
Amine Segueni
Stacy Jones
Jason Elenberger
Amy Reyna
Kathryn McSpadden
Aslam Khan
Monique Langston
Benjamin Marcum
Ronald M Pucillo
Parkway Medical Center
Recruiting
Birmingham,Alabama,35215,United States
James Sullivan
Biopharma Informatic LLC
Recruiting
Houston,Texas,77084,United States
Shah Mohammed
Syed Humayun Naqvi
Christian Assad-Kottner
Clarisa Garza
Imran Afridi
Velocity Clin Research Springdale
Recruiting
Cincinnati,Ohio,45246,United States
Douglas K Logan
Synexus Clinical Research US Inc
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Chicago,Illinois,60602,United States
Joseph Newberg
Proactive Clinical Research
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Fort Lauderdale,Florida,33308,United States
David Mishkin
Juan Garcia
Maria Coimbra
Virginia Commonwealth University
Recruiting
Richmond,Virginia,23298-0111,United States
Joshua West
Anurag Mehta
Johns Hopkins University
Recruiting
Columbia,Maryland,21044,United States
Daniel Kim
Plano Primary Care Clinic
Recruiting
Allen,Texas,75002-3688,United States
Muhammad Moin Farooqi
CV Ins of the South
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Opelousas,Louisiana,70570,United States
siby george ayalloore
Grady Health System
Recruiting
Atlanta,Georgia,30303,United States
Jalal Ghali
Stern Cardiovascular Foundation Inc
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Southaven,Mississippi,38671,United States
Dharmesh Patel
Baptist Health Medical Group
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Miami,Florida,33173,United States
Adedapo Iluyomade
Long Beach Clinical Trials
Recruiting
Long Beach,California,90806,United States
Suzanne Fussell
Ascension Saint Agnes Heart Care
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Baltimore,Maryland,21229,United States
Martin Albornoz
Velocity Clinical Trials
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Los Angeles,California,90057,United States
Stanley Hsin-Wei Hsia
Virginia Heart
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Falls Church,Virginia,22042,United States
Tariq Haddad
Angiocardiac Care of Texas PA
Recruiting
Houston,Texas,77025,United States
Amin Karim
Mid Hudson Medical Research PLLC
Recruiting
New Windsor,New York,12553,United States
Cardiology Partners Clinical Research Institute
Recruiting
Wellington,Florida,33449,United States
Duccio Baldari
Valley Clinical Trials Inc
Recruiting
Covina,California,91723,United States
Fahed Bitar
Mannie Lyons
Flint Clinical Research
Recruiting
Flint,Michigan,48503,United States
Khalid Ahmed
Columbus Clinical Services LLC
Recruiting
Miami,Florida,33125,United States
Sara Llerena
Apex Cardiology Research Associates of Jackson
Recruiting
Jackson,Tennessee,38301,United States
Mohsin Alhaddad
Overlook Medical Center
Recruiting
Summit,New Jersey,07901,United States
Robert Fishberg
TBC Research LLC
Recruiting
Tamarac,Florida,33321,United States
Barry Streit
Ricardo Zambrano
Capitol Cardiology Associates
Recruiting
Lanham,Maryland,20706,United States
Vineet Venugopal
Hometown Urgent Care and Research
Recruiting
Columbus,Ohio,43214,United States
Steve Choi
University of Washington
Recruiting
Seattle,Washington,98195,United States
Francis Kim
Lily Zavala
American Institute of Research
Recruiting
Los Angeles,California,90017,United States
Anil Mohin
Southern Clin Research Clinic
Recruiting
Zachary,Louisiana,70791,United States
Ernest Thompson
Tammy Dours
Cardiovascular Associates Research
Recruiting
Covington,Louisiana,70433,United States
Dale Presser
Las Vegas Endocrinology
Recruiting
Henderson,Nevada,89074,United States
Quang Nguyen
Johns Hopkins Univ School of Med
Recruiting
Baltimore,Maryland,21287,United States
Thorsten Leucker
Acclaim Clinical Research
Recruiting
San Diego,California,92120,United States
John Beckes
Wake Forest Health Network LLC
Recruiting
Asheboro,North Carolina,27203,United States
Robert Dough
Stacy Jones
National Heart Institute
Recruiting
Beverly Hills,California,90211,United States
Norman Lepor
Javara Research
Recruiting
San Marcos,Texas,78666,United States
Alan Lee
Cambridge Medical Trials
Recruiting
Alexandria,Louisiana,71301,United States
Naseem A Jaffrani
Eminat LLC
Recruiting
Miramar,Florida,33027,United States
Yaneth Trujillo
Optimal Research LLC
Recruiting
Huntsville,Alabama,35802,United States
Jared-Robert Blake
Randle T Middleton
Epic Clinical Research
Recruiting
Lewisville,Texas,75057,United States
Manjoo Sharma
Chicago Clinical Research Inst
Recruiting
Chicago,Illinois,60607,United States
Dennis Levinson
Clinical Trials of Florida
Recruiting
Miami,Florida,33186,United States
Mark Rosenthal
North Hills Medical Research Inc
Recruiting
Bedford,Texas,76021,United States
John D Gabriel
Excel Medical Clinical Trials LLC
Recruiting
Boca Raton,Florida,33434,United States
David Funt
Dominion Medical Associates
Recruiting
Richmond,Virginia,23219,United States
Richard A Jackson
Morehouse School Of Medicine
Recruiting
Atlanta,Georgia,30310,United States
Priscilla Igho-Pemu
Aa Mrc Llc
Recruiting
Flint,Michigan,48504,United States
Ahmed Arif
Rania Takriti
Finlay Medical Research
Recruiting
Miami,Florida,33126,United States
Lilia Rodriguez-Ables
TCV Clinical Studies
Recruiting
Linwood,Pennsylvania,19061,United States
Edward Stankiewicz
Jocelynn Vega
University At Buffalo
Recruiting
Buffalo,New York,14203,United States
Thomas Cimato
New Tampa Health
Recruiting
Tampa,Florida,33603,United States
Esther Echevarria-Crespo
Loraine Gonzalez
Pharma Tex Research
Recruiting
Amarillo,Texas,79106,United States
David Brabham
MD Medical Research
Recruiting
Oxon Hill,Maryland,20745,United States
John Hakim
NexGen Research
Recruiting
Lima,Ohio,45801,United States
Nonso Ezema
Clinical Research of South Nevada
Recruiting
Las Vegas,Nevada,89121,United States
Roger Estevez
Angel City Research Inc
Recruiting
Los Angeles,California,90026,United States
Felix Sigal
Joanna Cuevas
Sinai Ct for Throm Res and Drug Dev
Recruiting
Baltimore,Maryland,21209,United States
Paul Gurbel
Anderson Medical Research
Recruiting
Fort Washington,Maryland,20744,United States
Felton Anderson
Monroe Biomedical Research
Recruiting
Monroe,North Carolina,28112,United States
Awawu Igbinadolor
Heart Care Associates P C
Recruiting
Hopewell,Virginia,23860,United States
Kamlesh Dave
Metropolitan Cardiovascular Consultants Llc
Recruiting
Beltsville,Maryland,20705,United States
Ayim Akyea-Djamson
Ventura Heart Institute
Recruiting
Thousand Oaks,California,91360,United States
Irving Kent Loh
Rocio Ma
DBC Research USA
Recruiting
Pembroke Pines,Florida,33029,United States
Alvaro Murcia
NICRs Research Center
Recruiting
Garden Grove,California,92844,United States
Mallu Reddy
Vincent Ribaya
Ctr For Clin Rsrch And Innovation
Recruiting
Spring,Texas,77389,United States
Jorge Guerrero
Omega Clinical Research
Recruiting
Metairie,Louisiana,70006,United States
Tuan-Huy Tran
Zenith Clinical Research
Recruiting
Hollywood,Florida,33021,United States
Moises Issa
Synexus
Recruiting
Glendale,Arizona,85306,United States
Elysa Shaw
Tahmina Stanikzai
Discovery Clinical Trials
Recruiting
Pflugerville,Texas,78660-3015,United States
Brian K MacGillivray
CTMD Research
Recruiting
Palm Springs,Florida,33406,United States
Luis Castillo
David Turbay MD PLLC
Recruiting
El Paso,Texas,79905,United States
David Turbay
Atlanta Heart Specialists LLC
Recruiting
Tucker,Georgia,30084,United States
David Suh
C and A Clinical Trials
Recruiting
Cape Coral,Florida,33990,United States
Arturo Alvarez
Juan Antonio Carmona Herrera
Synexus Clinical Research Advantage
Recruiting
Birmingham,Alabama,35211,United States
William Kirby
Elite Clinical Research LLC
Recruiting
Jackson,Mississippi,39211,United States
Honey East
International Research Associates, LLC
Recruiting
Miami,Florida,33156,United States
Cristian Breton
Juan J Calderon
Sugar Lakes Family Practice
Recruiting
Sugar Land,Texas,77479,United States
John Vanderzyl
The Stern Cardiovascular Foundation
Recruiting
Germantown,Tennessee,38138,United States
Frank Augustus McGrew
Jamaica Hospital Medical Center
Recruiting
Jamaica,New York,11418,United States
David Coven
James A Haley Veterans Hospital
Recruiting
Tampa,Florida,33612,United States
David Whitaker
SW Family Medicine Associates
Recruiting
Dallas,Texas,75235,United States
Chrisette Dharma
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