The effect of early Landiolol in patients with ST-elevation acute coronary syndrome undergoing primary percutaneous coronary intervention – A prospective, randomized, double-blinded, placebo-controlled, phase IV pilot trial (STEMILAND-1)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2025-12-14

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective is to evaluate the feasibility of very early continuous i.v. administration of the highly cardioselective betablocker Landiolol in anterior/lateral ST-elevation acute coronary syndrome (STE-ACS).

Secondary objectives 4

1. The effect of i.v. administered Landiolol before-, during- and 24h after PCI on the incidence of dysrhythmia.
2. Cardiac enzymes (high-sensitive troponin-T, NT-proBNP, CK, CK-MB) and dynamics in electrocardiograms (ECG) at various time-points, as well as biobanking for future analysis of markers of endothelial function, myocardial function, and inflammation.
3. Number of adverse events, Hemodynamic instability, Number of re-hospitalizations, MACE and all-cause mortality.
4. Change of left ventricular ejection fraction (LVEF) in follow-up echocardiography from baseline LVEF (evaluated by standardized echocardiography)

Conditions and MedDRA coding

ST-elevation acute coronary syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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)
2. Treated at our study center
3. Age >= 18 years
4. Hemodynamically stable (MAP >60 mmHg, heart rate > 70/min)
5. Oral and written informed consent

Exclusion criteria 11

1. Known or suspected pregnancy
2. Known pathologies of the cardiac electrical conduction system (e.g., sick-sinus-syndrome, AV-block II° or III°)
3. Acute heart failure and cardiogenic Shock (Killip Classes III and IV)
4. Allergy or insensitivity to ß-blockers
5. Known pulmonary hypertension
6. Known pheochromocytoma
7. Anticipated time to wire-crossing >120 minutes after first medical contact
8. Thrombolysis candidate as defined by treating physician
9. Heart rate < 50 bpm
10. Acute asthma exacerbation
11. Severe metabolic acidosis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of enrolled patients who receive a continuous IV infusion of landiolol for 24 hours with no single interruption > 1 hour.

Secondary endpoints 12

1. 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).
2. 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
3. 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
4. Atrioventricular block (AV-Block II or III) and/or Bradycardia below 45/min within the first 24 hours
5. 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
6. Deterioration of heart failure
7. Suspected Allergic / anaphylactic reaction
8. 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
9. Number of re-hospitalizations due to cardiovascular reason within 90 days
10. 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
11. All-cause mortality within 6 month
12. 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)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Department of Emergency Medicine

Public contact point

Organisation

Medical University Of Vienna

Contact name

Department of Emergency Medicine

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications