Study Description
This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304). This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.
Interventions
Pelacarsen (TQJ230)
Eligibility Criteria
Inclusion Criteria:
* Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
* Participants who have completed the parent study and received the assigned study treatment at the time of its completion
Exclusion Criteria:
* Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study
* Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation
* Participants who are receiving another investigational drug or device before the open-label treatment period
* Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator
Other protocol-defined inclusion/exclusion criteria may apply.
Angiocardiac Care of Texas PA
Recruiting
Houston,Texas,77025,United States
Amin Karim
Henry Ford Hospital
Recruiting
Detroit,Michigan,48202,United States
Kayla A Woelmer
Sachin Parikh
Clinical Research of South Nevada
Recruiting
Las Vegas,Nevada,89121,United States
Roger Estevez
Apex Cardiology Research Associates of Jackson
Recruiting
Jackson,Tennessee,38301,United States
Mohsin Alhaddad
North Hills Medical Research Inc
Recruiting
Bedford,Texas,76021,United States
John D Gabriel
Capitol Cardiology Associates
Recruiting
Lanham,Maryland,20706,United States
Vineet Venugopal
Biopharma Informatic LLC
Recruiting
Houston,Texas,77084,United States
Alejandra Garcia
Christian Assad-Kottner
Syed Humayun Naqvi
Clinical Trials of Texas
Recruiting
San Antonio,Texas,78229,United States
Douglas Denham
Javara Research
Recruiting
Alexandria,Virginia,22311,United States
Amine Segueni
Virginia Heart
Recruiting
Falls Church,Virginia,22042,United States
Tariq Haddad
Anderson Medical Research
Recruiting
Fort Washington,Maryland,20744,United States
Felton Anderson
Lian Glorioso
Felton Anderson
Lian Glorioso
Finlay Medical Research
Recruiting
Miami,Florida,33126,United States
Lilia Rodriguez-Ables
Parkway Medical Center
Recruiting
Birmingham,Alabama,35215,United States
James Sullivan
National Heart Institute
Recruiting
Beverly Hills,California,90211,United States
Norman Lepor
Excel Medical Clinical Trials LLC
Recruiting
Boca Raton,Florida,33434,United States
Michael Hafran
Proactive Clinical Research
Recruiting
Fort Lauderdale,Florida,33308,United States
David Mishkin
National Research Institute
Recruiting
Hialeah,Florida,33013,United States
Carolina Ramirez
Raul Alonso
Inpatient Research Clinical LLC
Recruiting
Miami Lakes,Florida,33014,United States
Alexis Gutierrez
DBC Research USA
Recruiting
Pembroke Pines,Florida,33029,United States
Alvaro Murcia
Cardiology Partners Clinical Research Institute
Recruiting
Wellington,Florida,33449,United States
Duccio Baldari
Cardiovascular Associates Research
Recruiting
Covington,Louisiana,70433,United States
Dale Presser
Lori Barringer
Southern Clin Research Clinic
Recruiting
Zachary,Louisiana,70791,United States
Ernest Thompson
Tammy Dours
Worldwide Contacts
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