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).
The study will consist of a screening period of approximately 30 days, followed by a Guideline recommended SoC implementation period of approximately 30 days, if required, and a doubleblind treatment period of 12 months. There will be a post-treatment follow-up period of 16 weeks.
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
Eminat LLC
Recruiting
Miramar,Florida,33027,United States
Yaneth Trujillo
Dominion Medical Associates
Recruiting
Richmond,Virginia,23219,United States
Richard A Jackson
Anderson Medical Research
Recruiting
Fort Washington,Maryland,20744,United States
Felton Anderson
Proactive Clinical Research
Recruiting
Fort Lauderdale,Florida,33308,United States
David Mishkin
Clinical Trials of Texas .
Recruiting
San Antonio,Texas,78229,United States
Douglas Denham
Cambridge Medical Trials .
Recruiting
Alexandria,Louisiana,71301,United States
Naseem A Jaffrani
Valley Clinical Trials Inc
Recruiting
Covina,California,91723,United States
Fahed Bitar
Mannie Lyons
Pharma Tex Research
Recruiting
Amarillo,Texas,79106,United States
David Brabham
AB Clinical Trials
Recruiting
Las Vegas,Nevada,89119,United States
Atoya Adams
Cardiovascular Associates Research
Recruiting
Covington,Louisiana,70433,United States
Dale Presser
DBC Research USA
Recruiting
Pembroke Pines,Florida,33029,United States
Alvaro Murcia
Ctr For Clin Rsrch And Innovation Research
Recruiting
Spring,Texas,77389,United States
Adriana Mccray
Amie Sun-Wright
Zenith Clinical Research
Recruiting
Hollywood,Florida,33021,United States
Moises Issa
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
Clinical Research of South Nevada .
Recruiting
Las Vegas,Nevada,89121,United States
Roger Estevez
Southern Clinical Research Clinic .
Recruiting
Zachary,Louisiana,70791,United States
Ernest Thompson
Tammy Dours
Grady Health System
Recruiting
Atlanta,Georgia,30303,United States
Jalal Ghali
Virginia Heart
Recruiting
Falls Church,Virginia,22042,United States
Tariq Haddad
Inpatient Research Clinical LLC
Recruiting
Miami Lakes,Florida,33014,United States
Alexis Gutierrez
C and A Clinical Trials
Recruiting
Cape Coral,Florida,33990,United States
Arturo Alvarez
Juan Antonio Carmona Herrera
SW Family Medicine Associates
Recruiting
Dallas,Texas,75235,United States
Chrisette Dharma
Cardiology and Medicine Clinic, PA
Recruiting
Little Rock,Arkansas,72204,United States
Joe L Hargrove
Apex Cardiology Research Associates of Jackson
Recruiting
Jackson,Tennessee,38301,United States
Mohsin Alhaddad
Worldwide Contacts
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