This study is in progress, not accepting new patients

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

a study on Cardiovascular Disease Heart Attack Stroke

Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
study ends around

Description

Summary

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)

Official Title

A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With Established Cardiovascular Disease

Keywords

Cardiovascular Disease and Lipoprotein(a), Lipoprotein(a),, Lp(a),, CVD,, myocardial infarction,, PAD,, Stroke,, Pelacarsen, Cardiovascular Diseases, Myocardial Infarction, Stroke, TQJ230

Eligibility

You can join if…

Open to people ages 18-80

  • 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

You CAN'T join if...

  • 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

  • University of Calif Irvine Med Cntr
    Irvine California 92660 United States
  • Helping Hands Medical Associates INC
    Santa Ana California 92704 United States
  • Novartis Investigative Site
    Santa Ana California 92704 United States
  • Diabetes Lipid Management Center
    Huntington Beach California 92648 United States
  • Novartis Investigative Site
    Huntington Beach California 92648 United States
  • Novartis Investigative Site
    Orange California 92868 United States
  • Memorial Care Health System
    Long Beach California 90806 United States
  • Novartis Investigative Site
    Long Beach California 90806 United States
  • Novartis Investigative Site
    Los Angeles California 90073 United States
  • Flourish Clinical Resrch Covin
    Covina California 91723 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT04023552
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 8323 people participating
Last Updated