Your session is about to expire
← Back to Search
Antisense Oligonucleotide
Pelacarsen for Cardiovascular Disease (Lp(a)HORIZON Trial)
Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinically significant symptomatic peripheral artery disease
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 years
Awards & highlights
Lp(a)HORIZON Trial 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).
Who is the study for?
This trial is for people with cardiovascular disease who've had a heart attack or ischemic stroke between 3 months and 10 years ago, or have significant peripheral artery disease. They must also have high levels of Lp(a), a type of cholesterol particle, as confirmed by the central lab. It's not open to those with active liver disease, severe kidney issues, uncontrolled blood pressure, advanced heart failure, low platelets count, cancer history or recent major bleeding.Check my eligibility
What is being tested?
The study tests Pelacarsen (TQJ230) to see if it can reduce the risk of serious heart events in patients with existing cardiovascular conditions and elevated Lp(a). Participants will either receive TQJ230 or a placebo without knowing which one they're getting to compare outcomes fairly.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions at the injection site, liver problems due to drug metabolism changes, possible kidney function impact given its exclusion criteria and general discomforts like fatigue or nausea.
Lp(a)HORIZON Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe leg pain due to poor blood circulation.
Lp(a)HORIZON Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years
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)
Lp(a)HORIZON 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 Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,189,027 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious kidney condition.I have severe leg pain due to poor blood circulation.I had a heart attack between 3 months and 10 years ago.My heart condition severely limits my physical activity.My high blood pressure is not under control.I have had a major bleeding event or a stroke caused by bleeding.I had a stroke between 3 months and 10 years ago.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?I have had cancer in any part of my body before.I have liver disease or a liver condition.
Research Study Groups:
This trial has the following groups:- Group 1: TQJ230
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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+
Why did patients apply to this trial?
To learn more about my heart diease. To help others and I have heart disease.
PatientReceived 1 prior treatment
Not having much success with current meds. I am not satisfied with current results from my treatment.
PatientReceived no prior treatments
I am seeking improve my cardiovascular health in any way possible.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Length, duration, #of visits and payment for trial, please?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Novartis Investigative Site: < 48 hours
Average response time
- < 2 Days
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger