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NCT04993664NAWITHDRAWN

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

Influence of Pelacarsen on Arterial Wall Properties and Risk Factors in Patients After Myocardial Infarction With High Lp(a) Values

Sponsor: University Medical Centre Ljubljana

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Acute Coronary Syndrome, Lipoproteinemia, Inflammation, Genetic Polymorphisms
Interventions
Pelacarsen (TQJ230), Placebo
Enrollment
Primary completion
Jun 2022
Study completion
Oct 2022
First posted
Aug 2021
Last updated
Jan 2022

Primary Endpoints (CT.gov)

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

Time frame: Baseline

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

Time frame: Baseline

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

Time frame: Baseline

Eligibility 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), * significan

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov