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 UCSD UCSF
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, Counterfeit Drugs, 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 California San Diego
    San Diego 5391811 California 5332921 92103 United States
  • UCSF
    San Francisco 5391959 California 5332921 94115 United States
  • Cardiovascular Res Found
    Beverly Hills 5328041 California 5332921 90210 United States
  • Novartis Investigative Site
    La Jolla 5363943 California 5332921 92037 United States
  • Novartis Investigative Site
    Beverly Hills 5328041 California 5332921 90211 United States
  • Novartis Investigative Site
    San Francisco 5391959 California 5332921 94158 United States
  • Novartis Investigative Site
    Santa Ana 5392900 California 5332921 92704 United States
  • Novartis Investigative Site
    Huntington Beach 5358705 California 5332921 92648 United States
  • Novartis Investigative Site
    Orange 5379513 California 5332921 92868 United States
  • Novartis Investigative Site
    Northridge 5377985 California 5332921 91325 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