A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Description

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

Conditions

Aortic Stenosis

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Study Overview

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Study Details

Study overview

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis [Lp(a)FRONTIERS CAVS]

A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Condition
Aortic Stenosis
Intervention / Treatment

-

Contacts and Locations

Huntsville

Heart Center Research Llc ., Huntsville, Alabama, United States, 35801

Beverly Hills

Cardiovascular Res Found, Beverly Hills, California, United States, 90210

Beverly Hills

National Heart Institute, Beverly Hills, California, United States, 90211

Northridge

Valley Clinical Trials, Northridge, California, United States, 91325

Boca Raton

Excel Medical Clinical Trials LLC, Boca Raton, Florida, United States, 33434

Naples

Advanced Research for Health Improvement LLC, Naples, Florida, United States, 34102

Overland Park

Midwest Heart and Vascular Spec, Overland Park, Kansas, United States, 66211

Boston

Massachusetts General Hospital Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Brigham and Womens Hosp Harvard Med School ., Boston, Massachusetts, United States, 02115

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male and female ≥50 to \<80 years of age
  • * Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
  • * Mild or moderate calcific aortic valve stenosis
  • * At the randomization visit, participant must be optimally treated for existing CV risk factors
  • * Severe calcific aortic valve stenosis
  • * Uncontrolled hypertension
  • * 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

Ages Eligible for Study

50 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2029-01-03