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

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana

Criteria

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.