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 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
VA Caribbean Healthcare System
Recruiting
San Juan,00921,Puerto Rico
Luis Rodriguez-Ospina
CAIMED Center
Recruiting
Ponce,00716,Puerto Rico
Elizabeth A. Barranco
Flourish Research
Recruiting
Grandwood Park,Illinois,60031,United States
Alfonso Gonzales-Rodriguez
Angelica Perez
Daniel Stokes
Sara Collins
Dominion Medical Associates
Recruiting
Richmond,Virginia,23219,United States
Richard A Jackson
Hometown Urgent Care and Research
Recruiting
Columbus,Ohio,43214,United States
Steve Choi
Sister Life Research Inc
Recruiting
Hialeah,Florida,33013,United States
Luis Cabrera Haber
Idania Cruz
Raul Alonso
Javara Research
Recruiting
Alexandria,Virginia,22311,United States
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
Chelsi Holliday
Aimee Kaczorowsi
Sangeeta Wagner
Excel Medical Clinical Trials LLC
Recruiting
Boca Raton,Florida,33434,United States
David Funt
Capitol Cardiology Associates
Recruiting
Lanham,Maryland,20706,United States
Vineet Venugopal
National Heart Institute
Recruiting
Beverly Hills,California,90211,United States
Norman Lepor
North Hills Medical Research Inc
Recruiting
Bedford,Texas,76021,United States
John D Gabriel
CTMD Research
Recruiting
Palm Springs,Florida,33406,United States
Luis Castillo
University of Washington
Recruiting
Seattle,Washington,98195,United States
Francis Kim
Lily Zavala
Eminat LLC
Recruiting
Miramar,Florida,33027,United States
Yaneth Trujillo
Las Vegas Endocrinology
Recruiting
Henderson,Nevada,89074,United States
Quang Nguyen
Sinai Ct for Throm Res and Drug Dev
Recruiting
Baltimore,Maryland,21209,United States
Paul Gurbel
Biopharma Informatic LLC
Recruiting
Houston,Texas,77084,United States
Syed Humayun Naqvi
Christian Assad-Kottner
Clarisa Garza
Imran Afridi
Shah Mohammed
Johns Hopkins Univ School of Med
Recruiting
Baltimore,Maryland,21287,United States
Thorsten Leucker
Atlanta Heart Specialists LLC
Recruiting
Tucker,Georgia,30084,United States
David Suh
Pharma Tex Research
Recruiting
Amarillo,Texas,79106,United States
David Brabham
Wake Forest Health Network LLC
Recruiting
Asheboro,North Carolina,27203,United States
Stacy Jones
Robert Dough
Ventura Heart Institute
Recruiting
Thousand Oaks,California,91360,United States
Rocio Ma
Irving Kent Loh
Optimal Research LLC
Recruiting
Huntsville,Alabama,35802,United States
Randle T Middleton
Jared-Robert Blake
TCV Clinical Studies
Recruiting
Linwood,Pennsylvania,19061,United States
Edward Stankiewicz
Jocelynn Vega
International Research Associates, LLC
Recruiting
Miami,Florida,33156,United States
Cristian Breton
Juan J Calderon
Proactive Clinical Research
Recruiting
Fort Lauderdale,Florida,33308,United States
Maria Coimbra
David Mishkin
Juan Garcia
Aa Mrc Llc
Recruiting
Flint,Michigan,48504,United States
Ahmed Arif
Rania Takriti
Omega Clinical Research
Recruiting
Metairie,Louisiana,70006,United States
Tuan-Huy Tran
Angel City Research Inc
Recruiting
Los Angeles,California,90026,United States
Felix Sigal
Joanna Cuevas
James A Haley Veterans Hospital
Recruiting
Tampa,Florida,33612,United States
David Whitaker
Anderson Medical Research
Recruiting
Fort Washington,Maryland,20744,United States
Felton Anderson
University At Buffalo
Recruiting
Buffalo,New York,14203,United States
Thomas Cimato
Javara Research
Recruiting
San Marcos,Texas,78666,United States
Alan Lee
MD Medical Research
Recruiting
Oxon Hill,Maryland,20745,United States
John Hakim
NexGen Research
Recruiting
Lima,Ohio,45801,United States
Nonso Ezema
Epic Clinical Research
Recruiting
Lewisville,Texas,75057,United States
Manjoo Sharma
NICRs Research Center
Recruiting
Garden Grove,California,92844,United States
Mallu Reddy
Vincent Ribaya
DBC Research USA
Recruiting
Pembroke Pines,Florida,33029,United States
Alvaro Murcia
Clinical Research of South Nevada
Recruiting
Las Vegas,Nevada,89121,United States
Roger Estevez
Ascension Saint Agnes Heart Care
Recruiting
Baltimore,Maryland,21229,United States
Martin Albornoz
Metropolitan Cardiovascular Consultants Llc
Recruiting
Beltsville,Maryland,20705,United States
Ayim Akyea-Djamson
Monroe Biomedical Research
Recruiting
Monroe,North Carolina,28112,United States
Awawu Igbinadolor
CV Ins of the South
Recruiting
Opelousas,Louisiana,70570,United States
siby george ayalloore
Synexus
Recruiting
Glendale,Arizona,85306,United States
Elysa Shaw
Tahmina Stanikzai
Zenith Clinical Research
Recruiting
Hollywood,Florida,33021,United States
Moises Issa
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
David Turbay MD PLLC
Recruiting
El Paso,Texas,79905,United States
David Turbay
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
SW Family Medicine Associates
Recruiting
Dallas,Texas,75235,United States
Chrisette Dharma
Elite Clinical Research LLC
Recruiting
Jackson,Mississippi,39211,United States
Honey East
The Stern Cardiovascular Foundation
Recruiting
Germantown,Tennessee,38138,United States
Frank Augustus McGrew
Baptist Health Medical Group
Recruiting
Miami,Florida,33173,United States
Adedapo Iluyomade
Heart Care Associates P C
Recruiting
Hopewell,Virginia,23860,United States
Kamlesh Dave
Jamaica Hospital Medical Center
Recruiting
Jamaica,New York,11418,United States
David Coven
Velocity Clinical Trials
Recruiting
Los Angeles,California,90057,United States
Stanley Hsin-Wei Hsia
Ctr For Clin Rsrch And Innovation
Recruiting
Spring,Texas,77389,United States
Jorge Guerrero
Cardiology Partners Clinical Research Institute
Recruiting
Wellington,Florida,33449,United States
Duccio Baldari
AB Clinical Trials
Recruiting
Las Vegas,Nevada,89119,United States
Atoya Adams
Henry Ford Hospital
Recruiting
Detroit,Michigan,48202,United States
Sachin Parikh
Care Access Research
Recruiting
Easton,Pennsylvania,18045,United States
Eromonsele Idahosa
Jimmy Alele
Melissa Sexton
Rebecca Larimore
Columbus Clinical Services LLC
Recruiting
Miami,Florida,33125,United States
Sara Llerena
Grady Health System
Recruiting
Atlanta,Georgia,30303,United States
Jalal Ghali
Robert Wood Johnson Medical School
Recruiting
New Brunswick,New Jersey,08901,United States
Heena Gandhi
Tudor D Vagaonescu
Discovery Clinical Trials
Recruiting
Pflugerville,Texas,78660-3015,United States
Brian K MacGillivray
Long Beach Clinical Trials
Recruiting
Long Beach,California,90806,United States
Suzanne Fussell
TBC Research LLC
Recruiting
Tamarac,Florida,33321,United States
Barry Streit
Ricardo Zambrano
Velocity Clin Research Springdale
Recruiting
Cincinnati,Ohio,45246,United States
Douglas K Logan
Johns Hopkins University
Recruiting
Columbia,Maryland,21044,United States
Daniel Kim
Inpatient Research Clinical LLC
Recruiting
Miami Lakes,Florida,33014,United States
Alexis Gutierrez
Stern Cardiovascular Foundation Inc
Recruiting
Southaven,Mississippi,38671,United States
Dharmesh Patel
Southern Clin Research Clinic
Recruiting
Zachary,Louisiana,70791,United States
Ernest Thompson
Tammy Dours
Cardiology and Medicine Clinic PA
Recruiting
Little Rock,Arkansas,72204,United States
Joe L Hargrove
Acclaim Clinical Research
Recruiting
San Diego,California,92120,United States
John Beckes
Sugar Lakes Family Practice
Recruiting
Sugar Land,Texas,77479,United States
John Vanderzyl
Cambridge Medical Trials
Recruiting
Alexandria,Louisiana,71301,United States
Naseem A Jaffrani
Parkway Medical Center
Recruiting
Birmingham,Alabama,35215,United States
James Sullivan
Virginia Heart
Recruiting
Falls Church,Virginia,22042,United States
Tariq Haddad
Valley Clinical Trials Inc
Recruiting
Covina,California,91723,United States
Fahed Bitar
Mannie Lyons
Chicago Clinical Research Inst
Recruiting
Chicago,Illinois,60607,United States
Dennis Levinson
Plano Primary Care Clinic
Recruiting
Allen,Texas,75002-3688,United States
Muhammad Moin Farooqi
Clinical Trials of Florida
Recruiting
Miami,Florida,33186,United States
Mark Rosenthal
Virginia Commonwealth University
Recruiting
Richmond,Virginia,23298-0111,United States
Anurag Mehta
Joshua West
Apex Cardiology Research Associates of Jackson
Recruiting
Jackson,Tennessee,38301,United States
Mohsin Alhaddad
Morehouse School Of Medicine
Recruiting
Atlanta,Georgia,30310,United States
Priscilla Igho-Pemu
Finlay Medical Research
Recruiting
Miami,Florida,33126,United States
Lilia Rodriguez-Ables
Flint Clinical Research
Recruiting
Flint,Michigan,48503,United States
Khalid Ahmed
New Tampa Health
Recruiting
Tampa,Florida,33603,United States
Esther Echevarria-Crespo
Loraine Gonzalez
Cardiovascular Associates Research
Recruiting
Covington,Louisiana,70433,United States
Dale Presser
Overlook Medical Center
Recruiting
Summit,New Jersey,07901,United States
Robert Fishberg
Clinical Trials of Texas
Recruiting
San Antonio,Texas,78229,United States
Douglas Denham
American Institute of Research
Recruiting
Los Angeles,California,90017,United States
Anil Mohin
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.