Lowering Lipoprotein(a) to Slow Aortic Valve Stenosis Progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of pelacarsen (TQJ230), administered subcutaneously once a month, in slowing the progression of calcific aortic valve stenosis compared to a placebo. Participants will be adults aged 50 to 80 with elevated lipoprotein(a) levels and mild to moderate aortic stenosis. The study aims to determine if lowering lipoprotein(a) can positively impact the condition's progression. The trial is interventional and is conducted across multiple centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male and female ≥50 to \<80 years of age at Screening Part II
* 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

Exclusion Criteria:

* 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

Other protocol-defined inclusion/exclusion criteria may apply

Where it's running

• Heart Center Research Llc
  Huntsville, Alabama, United States Recruiting
• Cardiovascular Res Found
  Beverly Hills, California, United States Recruiting
• National Heart Institute
  Beverly Hills, California, United States Recruiting
• Flourish Clinical Resrch Covin
  Covina, California, United States Recruiting
• Valley Clinical Trials
  Northridge, California, United States Recruiting
• Stanford University Medical Center
  Palo Alto, California, United States Recruiting

+90 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.