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Pelacarsen for Calcific Aortic Valve Stenosis

This study is testing a drug called pelacarsen (TQJ230) to see if it can slow down the progression of calcific aortic valve stenosis (a condition where your heart valve narrows and hardens). You might be able to join if you are between 50 and 80 years old, have mild or moderate calcific aortic valve stenosis, and have high levels of a specific biomarker called Lp(a) (lipoprotein(a)) in your blood. Participants will receive either pelacarsen or a matching placebo (an inactive substance). Researchers will measure changes in how fast blood flows through your aortic valve and how much calcium is in your valve after 36 months to see if the treatment is effective. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 502 participants. It compares pelacarsen to a matching placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 36 months, indicating a follow-up period of at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05646381

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

Recruiting
PHASE2Ages 50–80InterventionalTreatment
Novartis Pharmaceuticals
~502 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Pelacarsen (TQJ230) 80mgMatching placebo

At a glance

Recruiting sites
130 of 140 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in peak aortic jet velocity
Measured over 36 months
+1 more outcome measured

Conditions

Aortic Stenosis

Explore related trials

Aortic Valve StenosisApolipoprotein(a)

Where it's being run

140 sites across 50 states
Germany11
United Kingdom10
Israel9
California7
Spain7
France6
Florida5
Massachusetts5

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in peak aortic jet velocity36 months

    To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography

  • Change in aortic valve calcium score36 months

    To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in aortic valve calcium score by computed tomography