Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD

NCT04023552

Active Not RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Cardiovascular Disease and Lipoprotein(a)

Interventions: TQJ230, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria

* Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory
* Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
* Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
* Clinically significant symptomatic peripheral artery disease

Key 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 ≤LLN
* Active liver disease or hepatic dysfunction
* Significant kidney disease
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply at the end.
Locations (904)
  • Andalusia, Alabama, United States
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Huntsville, Alabama, United States
  • Huntsville, Alabama, United States
  • Mobile, Alabama, United States
  • Mobile, Alabama, United States
  • Cottonwood, Arizona, United States
  • Gilbert, Arizona, United States
  • Sun City West, Arizona, United States
  • Sun City West, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Beverly Hills, California, United States
  • Beverly Hills, California, United States
  • Beverly Hills, California, United States
  • Covina, California, United States
  • Covina, California, United States
  • Huntington Beach, California, United States
  • Huntington Beach, California, United States
  • Irvine, California, United States
  • La Jolla, California, United States
  • Long Beach, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Northridge, California, United States
  • + 874 more on CT.gov