What side effects are associated with this type of intervention?

Common treatments for cardiovascular disease, such as statins and PCSK9 inhibitors, have well-documented side effects. Statins can cause muscle pain, liver enzyme abnormalities, and, in rare cases, rhabdomyolysis. PCSK9 inhibitors, like alirocumab and inclisiran, are generally well-tolerated but can cause injection site reactions, flu-like symptoms, and nasopharyngitis. Lipoprotein apheresis, another lipid-lowering therapy, can lead to hypotension, anemia, and allergic reactions. These side effects are important to consider when evaluating treatment options with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for cardiovascular disease that focus on lipid lowering. Statins, such as atorvastatin and rosuvastatin, are widely used to lower LDL cholesterol and have been shown to reduce cardiovascular events. PCSK9 inhibitors, including alirocumab and evolocumab, have also been approved for patients with high cardiovascular risk, significantly lowering LDL-C levels and reducing major cardiovascular events. Emerging RNA therapeutics, like inclisiran, have shown promise in reducing lipoprotein(a) levels, an independent risk factor for CVD, although specific FDA approval for Lp(a) lowering agents is still under investigation.

What other types of research exist?

Promising novel alternatives to Lipoprotein(a) lowering agents for reducing cardiovascular risk in CVD patients include PCSK9 inhibitors, anti-inflammatory therapies, and agents targeting HDL cholesterol modulation and endothelial function.

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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

Must not have

Significant kidney disease

Heart failure New York Heart Association (NYHA) class IV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a treatment to lower heart-related risks in patients who already have heart disease and high levels of a specific blood substance called Lp(a). Research is ongoing to find effective treatments for this condition.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I have severe leg pain due to poor blood circulation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious kidney condition.

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My heart condition severely limits my physical activity.

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My high blood pressure is not under control.

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I have had a major bleeding event or a stroke caused by bleeding.

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I have had cancer in any part of my body before.

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I have liver disease or a liver condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Change in Lp(a) in the log scale from baseline

Time to Clinical endpoint Committee 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

+1 more

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TQJ230

2019

Completed Phase 3

~8330

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cardiovascular Disease (CVD) include statins, PCSK9 inhibitors, and emerging therapies like lipoprotein(a) [Lp(a)] lowering agents. Statins work by inhibiting HMG-CoA reductase, reducing LDL cholesterol levels, and exerting anti-inflammatory effects. PCSK9 inhibitors, such as evolocumab and alirocumab, increase the number of LDL receptors on liver cells, enhancing the clearance of LDL cholesterol from the bloodstream. Lp(a) lowering agents, like pelacarsen, specifically target and reduce Lp(a) levels, which are independently associated with increased cardiovascular risk. These treatments are vital for CVD patients as they help manage lipid levels and reduce the risk of major cardiovascular events.

Lipoprotein(a) and proprotein convertase subtilisin/kexin type 9 inhibitors.Cardiovascular risk reduction: what do recent trials with rosuvastatin tell us?Atorvastatin.