Effect of Prehospital Pulse-Dose Methylprednisolone on All-Cause Mortality in Patients with ST-Segment Elevation Myocardial Infarction: A Randomized Controlled Trial
- Trial ID
- 2025-524320-21-00
- Sponsor
- Region Hovedstaden
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the effect of prehospital pulse-dose glucocorticoid administration on all-cause mortality compared to placebo in patients presenting with ST-segment elevation myocardial infarction. Secondary objectives include assessing the impact of treatment on cardiovascular mortality, spontaneous myocardial infarction, and heart failure admissions. Additionally, the study evaluates recurrent non-fatal cardiovascular events and the prognostic improvement in patients with type I myocardial infarction. Further analysis will determine if treatment responses vary across prespecified subgroups based on age, sex, left ventricular ejection fraction, infarction location, multivessel disease, time from symptom onset to intervention, and prior thrombolysis.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of male and female patients diagnosed with ST-segment elevation myocardial infarction. Eligible participants include adults aged 18 years and older, including fertile women, presenting with acute onset chest pain of less than 24 hours duration. Inclusion is based on electrocardiogram findings characterizing the acute myocardial infarction, such as specific ST-segment elevation patterns, a new left bundle branch block, or signs of posterior myocardial involvement. The study population includes vulnerable individuals.
Plans and Procedures
This Phase 3, therapeutic confirmatory trial is designed to evaluate the effect of prehospital pulse-dose glucocorticoid on all-cause mortality compared to a placebo in patients presenting with ST-segment elevation myocardial infarction. The study involves the administration of methylprednisolone via intravenous infusion or sodium chloride as a control. Eligible participants include adults with acute chest pain of less than 24 hours duration and specific electrocardiogram criteria indicating myocardial infarction. The primary endpoint is all-cause mortality, while secondary endpoints include cardiovascular mortality, spontaneous myocardial infarction, and admission for heart failure. The recruitment period is estimated to occur between April 2026 and April 2036.
Treatment
The experimental medication consists of methylprednisolone, provided as a solution for injection. The administered dose is 250 mg via intravenous infusion.
The control group receives a placebo consisting of sodium chloride in a 4 ml solution for injection, administered through intravenous infusion.
Efficacy
The efficacy of prehospital pulse-dose glucocorticoid in patients with ST-segment elevation myocardial infarction is evaluated through several predefined endpoints. The primary endpoint is all-cause mortality. Secondary endpoints include cardiovascular mortality, spontaneous myocardial infarction, and admission for heart failure. Additional composite outcomes consist of all-cause mortality or admission for heart failure, cardiovascular mortality or admission for heart failure, and recurrent non-fatal cardiovascular events, defined as spontaneous myocardial infarction and admission for heart failure, with death treated as a terminal event.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Age ≥18 years including fertile women
- Acute onset of chest pain with < 24 hours duration
- STEMI as characterized on electrocardiogram (ECG) by one of the following: a. at least two contiguous leads with ST-segment elevation ≥2.5 mm in men < 40 years, ≥2 mm in men ≥40 years, or ≥1.5 mm in women in leads V2-V3 and/or ≥1 mm in the other leads, b. presumed new left bundle branch block with ≥1 mm concordant ST-segment eleva-tion in leads with a positive QRS complex, or concordant ST-segment depression ≥1 mm in V1-V3, or discordant ST-segment elevation ≥5 mm in leads with a negative QRS complex c. Isolated ST depression ≥0.5 mm in leads V1-V3 and ST-segment elevation (≥0.5 mm) in posterior chest wall leads V7-V9 indicating posterior acute myocardial infarc-tion (AMI) d. ST-segment depression ≥1 mm in eight or more surface leads, coupled with ST-segment elevation in aVR and/or V1 suggesting left main-, or left main equivalent- coronary obstruction
Exclusion Criteria
- Suspected other than type I acute myocardial infarction at the time of potential randomization
- Initial presentation with cardiac arrest (out of hospital cardiac arrest)
- Known allergy to glucocorticoid
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Denmark | Recruiting | 15 Apr 2026 | 5204 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Natriumchlorid ”Noridem”,solvens til parenteral anvendelse/injektionsvæske, opløsning | Placebo | SOLVENS TIL PARENTERAL ANVENDELSE/INJEKTIONSVÆSKE, OPLØSNING | INTRAVENOUS INFUSION | 4 | 1 | PRD388433 |
SOLU-MEDROL 125 mg pulver och vätska till injektionsvätska, lösning | Test | PULVER OCH VÄTSKA TILL INJEKTIONSVÄTSKA, LÖSNING | INTRAVENIOUS INFUSION | 250 | 1 | PRD2076544 |