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Pelacarsen (TQJ230) 80mg for Aortic Stenosis

Phase 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mild or moderate calcific aortic valve stenosis

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Study Summary

"This trial aims to see if pelacarsen given as a monthly injection can slow down the progression of calcific aortic valve stenosis compared to a placebo."

Who is the study for?

This trial is for men and women aged 50 or older with a blood level of Lipoprotein(a) at or above 125 nmol/L, as measured by the central lab. Participants should have mild to moderate calcific aortic valve stenosis but no other details are provided about who might be excluded.Check my eligibility

What is being tested?

The study tests Pelacarsen (TQJ230), given as a monthly subcutaneous injection, against a placebo to see if it can slow down the worsening of calcific aortic valve stenosis—a heart condition where the valve narrows and hardens.See study design

What are the potential side effects?

While specific side effects aren't listed here, generally such injections could cause reactions at the injection site, potential liver issues due to lipid changes, allergic responses, and possibly influence bleeding risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart valve condition is not severe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in aortic valve calcium score

Change in peak aortic jet velocity

Secondary outcome measures

Change in Lp(a) levels

Change in fibrocalcific thickening of the aortic valve

Time from randomization to first occurrence of composite clinical endpoint event

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pelacarsen (TQJ230) 80mgExperimental Treatment1 Intervention

Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously

Group II: Matching placeboPlacebo Group1 Intervention

Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,865 Previous Clinical Trials

4,198,783 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria to participate in this research endeavor?

"Patients must suffer from aortic stenosis and be aged between 50 and 80 to qualify for inclusion in this research. The study aims to recruit 502 individuals in total."

Answered by AI

Are individuals above 70 years of age eligible to participate in this study?

"Individuals between the ages of 50 and 80 are eligible for participation in this research study. Notably, there is a total of 33 trials targeting subjects under 18 years old and 312 studies focusing on those above 65 years old."

Answered by AI

Has the 80mg dose of Pelacarsen (TQJ230) received approval from the FDA?

"Based on the current evaluation, Pelacarsen (TQJ230) 80mg is rated a 2 for safety by our team at Power. This rating reflects the Phase 2 trial stage where some data supports its safety profile but none yet demonstrate efficacy."

Answered by AI

Are prospective participants able to enroll in this research study at the present time?

"Affirmative. Information on clinicaltrials.gov indicates that this medical trial is actively seeking participants. The initial posting of the trial occurred on March 7, 2024, with the most recent update made on April 25, 2024. A total of 502 individuals are sought across nine designated sites."

Answered by AI

At how many distinct locations is this medical trial being administered?

"Participating sites in this medical research endeavor include Carient Heart and Vascular in Tyne And Wear, Excel Medical Clinical Trials LLC located in Manassas, as well as Advanced Research for Health Improvement LLC situated in Sainte Foy. Additionally, there are 9 more investigation centers dispersed across various locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05646381.

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