WithdrawnNot Applicable

Influence of Pelacarsen on Patients After Myocardial Infarction With High Lp(a) Values (PEMILA)

Stopped: Administrative reason

Slovenia0Started 2021-10-01

Plain-language summary

The aim of study is to examine the relationship between lipid subfractions, inflammation and structural-functional properties of the arterial wall in patients after myocardial infarction with high lipoprotein (a) (Lp (a)) levels, to study genetic polymorphisms that determine lipid subfractions concentration on the functional and morphological properties of the arterial vascular wall in patients after myocardial infarction with high Lp (a) levels, to study the effect of pelacarsen on lipid subfractions, inflammation and structural-functional properties of arterial wall in patients after myocardial infarction with high Lp (a) levels and to study the influence of NOS-3 gene expression on the functional and morphological properties of the arterial vascular wall in the same patients. Impaired blood fat metabolism and chronic inflammation represent possible causes of atherosclerosis. Lp (a) is an independent risk factor for cardiovascular disease and a prognostic predictor in patients after myocardial infarction. Despite recommended screening for elevated Lp (a), there is no specific drug treatment approved to reduce cardiovascular risk through lowering Lp (a). Besides subtilisin-kexin convertase type 9 (PCSK9) inhibitors, antisense oligonucleotides (ASOs) are currently only therapeutic agents that significantly reduce serum Lp (a) concentration. Pelacarsen by using an ASO directed against the messenger ribonucleic acid (mRNA) of apolipoprotein (a), reduces the production of apolipoprotein (a) in the liver and thus, the level of Lp (a). However, there are no data on the relationship between Lp (a) values and polymorphisms for Lp (a), indicators of inflammation and impaired arterial function, and response to treatment with pelacarsen in patients after myocardial infarction with extremely high Lp (a) levels.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * concentration Lp (a) above 700 mg / L, * optimally treated risk factors for cardiovascular events according to currently valid guidelines, * history of myocardial infarction having occurred in the period 3 months to 10 years prior to the screening visit and / or * history of ischemic stroke having occurred in the period 3 months to 10 years prior to the screening visit and / or * clinically significant symptomatic peripheral artery disease. Exclusion Criteria: * uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and / or diastolic blood pressure ≥ 100 mmHg), * heart failure New York Heart Association (NYHA) class IV, * history of malignancy of any organ system, * history of hemorrhagic stroke or other major bleeding, * platelet count \<140,000 per mm3, * active liver disease or hepatic dysfunction (elevated transaminases above 3 times the norm, elevated bilirubin above 2 times the norm, elevated creatinine kinase above 3 times the norm), * significant kidney disease (oGFR \<30 ml / min), * pregnant or nursing women, * life expectancy less than 5 years, * unwillingness to participate or lack of availability for follow-up.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ultrasound functional and morphological properties of the arterial wall and Lp (a) concentration

Timeframe: Baseline

Concentration of Lp (a) and SNP in the LPA gene

Timeframe: Baseline

The effect of pelacarsen on functional and morphological properties of arterial wall after 6 months

Timeframe: Baseline

Trial details

NCT IDNCT04993664

SponsorUniversity Medical Centre Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Acute Coronary Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Ultrasound functional and morphological properties of the arterial wall and Lp (a) concentration

Timeframe: Baseline

Concentration of Lp (a) and SNP in the LPA gene

Timeframe: Baseline

The effect of pelacarsen on functional and morphological properties of arterial wall after 6 months

Timeframe: Baseline