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Antisense Oligonucleotide

TQJ230 for Cardiovascular Disease

Novartis Investigative Site, Milwaukee, WI
TQJ230 +1 morePhase 3Waitlist AvailableResearch Sponsored by Novartis Pharmaceuticals

Study Summary

This trial will help to show if the drug reduces the risk of cardiovascular disease in patients who have already had a heart attack or stroke and who have high levels of Lp(a).

Eligible Conditions
  • Cardiovascular Disease and High Lp(a)

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have a serious and noticeable condition called peripheral artery disease that causes symptoms in your arms or legs.
Select...
You have significant symptoms related to peripheral artery disease.
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I'm sorry, I cannot provide a summary for the term "Key" as it is incomplete and does not provide enough context. Can you please provide more information?

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) ≥ 70 mg/dL
Time to the first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in a population of patients with elevated Lp(a) ≥ 90 mg/dL.
Secondary outcome measures
Number of participants with confirmed all-cause death
Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of coronary heart disease: coronary heart disease death, non-fatal MI, urgent coronary re-vascularization requiring hospitalization
Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of major adverse cardiovascular events (CV death, non-fatal MI, and non-fatal stroke)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TQJ230Experimental Treatment1 Intervention
TQJ230 80 mg injected monthly administered subcutaneously
Group II: PlaceboPlacebo Group1 Intervention
Monthly subcutaneous injections.

Find a site

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,799 Previous Clinical Trials
4,015,831 Total Patients Enrolled

Media Library

Pelacarsen (TQJ230) (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT04023552 — Phase 3
Cardiovascular Disease Research Study Groups: Placebo, TQJ230
Cardiovascular Disease Clinical Trial 2023: Pelacarsen (TQJ230) Highlights & Side Effects. Trial Name: NCT04023552 — Phase 3
Pelacarsen (TQJ230) (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04023552 — Phase 3
Cardiovascular Disease Patient Testimony for trial: Trial Name: NCT04023552 — Phase 3

Frequently Asked Questions

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

Is this study popular in Canada?

"There are 100 sites currently enrolling patients for this trial, with locations in Murray, Milwaukee, Kalamazoo, and 100 other cities. If you enroll in the trial, try to select a location near you to minimize travel requirements."

Answered by AI

Has TQJ230 received government sanctioning for public use?

"TQJ230 is a Phase 3 trial medication, which means that while there is some data suggesting its efficacy, there is also extensive data supporting its safety. Our team at Power gives it a score of 3."

Answered by AI

Are researchers still signing up participants for this clinical trial?

"No, this study is not currently recruiting patients. While the trial was originally posted on December 12th, 2019, the most recent update was on October 7th, 2022. There are 430 other studies actively recruiting patients at this time."

Answered by AI

Are the individuals taking part in this trial above the age of majority?

"In order to take part in this particular clinical trial, patients must be aged between 18 and 80 years old. If a patient falls outside of this age range, there are other options; 28 trials for those under 18 and 384 for seniors."

Answered by AI

Could I potentially qualify to take part in this medical research?

"Those with lipoproteins and between the ages of 18-80 are eligible to participate in this trial. A total of 8324 individuals can join."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Arkansas
California
Other
How old are they?
65+
What site did they apply to?
Novartis Investigative Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
2
3+

What questions have other patients asked about this trial?

Length, duration, #of visits and payment for trial, please?
Patient

Why did patients apply to this trial?

To learn more about my heart diease. To help others and I have heart disease.
Patient
Not having much success with current meds. I am not satisfied with current results from my treatment.
Patient
I am seeking improve my cardiovascular health in any way possible.
Patient

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
Journal of Cardiovascular PharmacologyJournal
The Role of Antisense Therapies Targeting Lipoprotein(a)
Plakogiannis, Roda, Maria Sorbera, Briann Fischetti, and Mandy Chen. 2021. “The Role of Antisense Therapies Targeting Lipoprotein(a)”. Journal of Cardiovascular Pharmacology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/fjc.0000000000001045.
JACC: Cardiovascular InterventionsJournal
Always Present, but Now Rediscovered
Tsimikas, Sotirios, Ryan R. Reeves, and Mitul P. Patel. 2021. “Always Present, but Now Rediscovered”. JACC: Cardiovascular Interventions. Elsevier BV. doi:10.1016/j.jcin.2021.08.032.
clinicaltrials.govStudy
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
2019. "Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04023552.
~2561 spots leftby May 2025
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