Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion 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, 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 California 92103 United States
  • Novartis Investigative Site
    La Jolla California 92037 United States

Details

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