Landiolol hydrochloride for ST-elevation acute coronary syndrome

Inclusion criteria

• {"criterion_text":"- Anterior or lateral ST-elevation acute coronary syndrome (STE-ACS; defined as ST-segment elevation in two or more of precordial leads V1-V6, and I and aVL, representing anterior wall infarction or ischemia)\n- Treated at our study center\n- Age >= 18 years\n- Hemodynamically stable (MAP >60 mmHg, heart rate > 70/min)\n- Oral and written informed consent"}

Exclusion criteria

• {"criterion_text":"- Known or suspected pregnancy\n- Acute asthma exacerbation\n- Severe metabolic acidosis\n- Known pathologies of the cardiac electrical conduction system (e.g., sick-sinus-syndrome, AV-block II° or III°)\n- Acute heart failure and cardiogenic Shock (Killip Classes III and IV)\n- Allergy or insensitivity to ß-blockers\n- Known pulmonary hypertension\n- Known pheochromocytoma\n- Anticipated time to wire-crossing >120 minutes after first medical contact\n- Thrombolysis candidate as defined by treating physician\n- Heart rate < 50 bpm"}

Primary endpoints

• {"endpoint_text":"- Proportion of enrolled patients who receive a continuous IV infusion of landiolol for 24 hours with no single interruption > 1 hour.","definition_or_measurement_approach":"Measured as the proportion of enrolled patients who receive continuous IV landiolol infusion for 24 hours with no interruption exceeding 1 hour (binary/completion outcome per patient)."}

Secondary endpoints

• {"endpoint_text":"- The effect of i.v. administered Landiolol before-, during- and 24h after PCI on the incidence of dysrhythmia (defined as occurrence of ventricular fibrillation, ventricular tachycardia, > 10 extrasystoles per minute, any bradycardia <40/min, any tachycardia >120/min).","definition_or_measurement_approach":"Incidence of dysrhythmia defined as occurrence of ventricular fibrillation, ventricular tachycardia, >10 extrasystoles/min, any bradycardia <40/min, or any tachycardia >120/min."}
• {"endpoint_text":"- Cardiac enzymes (high-sensitive troponin-T, NT-proBNP, CK, CK-MB) and dynamics in electrocardiograms (ECG) at admission, 6 hours, 12, hours, 18 hours, 24 hours and after 90 days, as well as biobanking for future analysis of markers of endothelial function, myocardial function, and inflammation","definition_or_measurement_approach":"Serial measurement of specified cardiac biomarkers at listed timepoints and ECG changes at those timepoints; samples stored for biobanking and future marker analyses."}
• {"endpoint_text":"- Unintended and not otherwised-induced (e.g., by administration of morphine or antihypertonic medication) blood pressure decrease of >20% based on the last blood pressure value before Landiolol application","definition_or_measurement_approach":"Occurrence of >20% drop in blood pressure relative to the last BP measurement before Landiolol, excluding decreases attributable to other medications."}
• {"endpoint_text":"- Atrioventricular block (AV-Block II or III) and/or Bradycardia below 45/min within the first 24 hours","definition_or_measurement_approach":"Occurrence of AV-Block II/III or heart rate <45/min within 24 hours of treatment."}
• {"endpoint_text":"- Cardiogenic shock (Killip III, IV): Systolic BP (SBP) < 90 mmHg for >30 min, catecholamine support to maintain SBP >90 mmHg, altered mental status, urine output <30 mL/h, cool extremities","definition_or_measurement_approach":"Clinical criteria for cardiogenic shock defined by Killip III/IV and listed physiological criteria."}
• {"endpoint_text":"- Deterioration of heart failure","definition_or_measurement_approach":"Clinical assessment of worsening heart failure (as recorded in study safety assessments)."}
• {"endpoint_text":"- Suspected Allergic / anaphylactic reaction","definition_or_measurement_approach":"Occurrence of suspected allergic/anaphylactic reactions as reported and adjudicated in safety monitoring."}
• {"endpoint_text":"- Hemodynamic instability defined as a blood pressure drop below 55 mmHg mean arterial pressure (MAP) for longer than 10 minutes (also in combination with the clinical picture – e.g., signs of cardiogenic shock, decompensated heart failure, etc.) within the first 24 hours","definition_or_measurement_approach":"MAP <55 mmHg for >10 minutes and/or associated clinical signs within first 24 hours."}
• {"endpoint_text":"- Number of re-hospitalizations due to cardiovascular reason within 90 days","definition_or_measurement_approach":"Count of cardiovascular-related re-hospitalizations within 90 days post-index event."}
• {"endpoint_text":"- Major adverse cardiac and cerebrovascular event (MACE) (Re-infarction (relevant change of 20% in troponin levels between two measurements and recurrence of ST-elevation ≥ 1 mm or new Q-waves in at least two contiguous leads within 28 days of a previous myocardial infarction, need for revascularization) Cardiovascular death/mortality, Early revascularization, Stroke, Heart failure, Stent-thrombosis) combined and separate within first 6 months","definition_or_measurement_approach":"Composite MACE and component events defined as listed; re-infarction definition includes ≥20% troponin change and recurrent ST-elevation ≥1 mm or new Q-waves within 28 days."}
• {"endpoint_text":"- All-cause mortality within 6 month","definition_or_measurement_approach":"All-cause death assessed up to 6 months after index event."}
• {"endpoint_text":"- Change of left ventricular ejection fraction (LVEF) in follow-up echocardiography after 90 days from baseline LVEF at admission within 48 hours (evaluated by standardized echocardiography)","definition_or_measurement_approach":"Change in LVEF from baseline (admission echocardiography within 48 hours) to follow-up echocardiography at 90 days using standardized echo assessment."}

Austria

Earliest CTIS Part Ii Submission Date

05-12-2025

Latest Decision Or Authorization Date

14-12-2025

Processing Time Days

9

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria