Clinical trial • Phase III • Cardiology

METHYLPREDNISOLONE for ST-segment elevation myocardial infarction (STEMI)

Phase III trial of METHYLPREDNISOLONE for ST-segment elevation myocardial infarction (STEMI).

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
ST-segment elevation myocardial infarction (STEMI)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
23-12-2025
First CTIS Authorization Date
11-03-2026

Trial design

Randomised, placebo: intravenous infusion of 4 ml isotonic nacl (0.9%) over a period of 5 minutes; active comparator: 2 x 125 mg/2 ml solu-medrol (total 250 mg/4 ml), sterile powder reconstituted with isotonic nacl and infused over a period of 5 minutes.-controlled Phase III trial across 4 sites in Denmark.

Randomised
Yes
Comparator
Placebo: Intravenous infusion of 4 mL isotonic NaCl (0.9%) over a period of 5 minutes; Active comparator: 2 x 125 mg/2 mL Solu-Medrol (total 250 mg/4 mL), sterile powder reconstituted with isotonic NaCl and infused over a period of 5 minutes.
Target Sample Size
5204
Trial Duration For Participant
3654

Eligibility

Recruits 5204 isVulnerablePopulationSelected is true in the record. Subject information and informed consent forms include specific documents for guardians/representatives and parental/guardian versions (document titles: 'Forsgsvrgeinformation', 'Parrendeinformation', 'Parrende- og forsgsvrgesamtykke_vek', 'Rettigheder som forsgsperson VEK', etc.). Primary consent appears to be by the adult participant (eligible age ≥18), with separate information/consent documents prepared for situations involving representatives/guardians. No explicit assent procedures are provided in the available metadata. Document titles are in Danish..

Vulnerable Population
isVulnerablePopulationSelected is true in the record. Subject information and informed consent forms include specific documents for guardians/representatives and parental/guardian versions (document titles: 'Forsgsvrgeinformation', 'Parrendeinformation', 'Parrende- og forsgsvrgesamtykke_vek', 'Rettigheder som forsgsperson VEK', etc.). Primary consent appears to be by the adult participant (eligible age ≥18), with separate information/consent documents prepared for situations involving representatives/guardians. No explicit assent procedures are provided in the available metadata. Document titles are in Danish.

Inclusion criteria

  • {"criterion_text":"- Age ≥18 years including fertile women\n- Acute onset of chest pain with < 24 hours duration\n- STEMI as characterized on electrocardiogram (ECG) by one of the following: a.\tat 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.\tpresumed 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.\tIsolated 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.\tST-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

  • {"criterion_text":"- Suspected other than type I acute myocardial infarction at the time of potential randomization\n- Initial presentation with cardiac arrest (out of hospital cardiac arrest)\n- Known allergy to glucocorticoid"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- All-cause mortality","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Cardiovascular mortality\n- Spontaneous myocardial infarction\n- Admission for heart failure\n- All-cause mortality or admission for heart failure\n- Cardiovascular mortality or admission for heart failure\n- Recurrent non-fatal cardiovascular events (spontaneous myocardial infarction and admission for heart failure) with death treated as a terminal event","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
5204
Recruitment Window Months
120
Consent Approach
Informed consent documented via subject information and informed consent forms (multiple versions available). Consent is provided by the adult participant (eligibility age ≥18). Separate/alternative information and consent documents for guardians/representatives and parental/guardian consent are included in the document list, indicating procedures for vulnerable/incapacitated participants. Documents appear to be in Danish (titles in Danish). No explicit multilingual options or assent procedures are described in the available metadata.

Geography

Total Number Of Sites
4
Total Number Of Participants
5204

Denmark

Earliest CTIS Part Ii Submission Date
06-03-2026
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
39
Number Of Sites
4
Number Of Participants
5204

Sites

Site Name
Aalborg University Hospital
Department Name
Heart Center, Department of Cardiology
Contact Person Name
Ashkan Eftekhari
Contact Person Email
asef@rn.dk
Site Name
Odense University Hospital
Department Name
Heart Center, Department of Cardiology
Contact Person Name
Lisette Okkels
Contact Person Email
Lisette.Okkels.Jensen@rsyd.dk
Site Name
Rigshospitalet
Department Name
Heart Center, Department of Cardiology
Contact Person Name
Jacob Lønborg
Site Name
Aarhus Universitet
Department Name
Heart Center, Department of Cardiology
Contact Person Name
Christian Terkelsen

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
SOLU-MEDROL 125 mg pulver och vätska till injektionsvätska, lösning
Active Substance
METHYLPREDNISOLONE
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Marketing authorisation number 6397 (authorised in FI)
Starting Dose
250 mg (2 x 125 mg/2 mL)
Dose Levels
250 mg
Frequency
Single pulse-dose, infused over 5 minutes
Maximum Dose
250 mg
Investigational Product Name
Natriumchlorid ”Noridem",solvens til parenteral anvendelse/injektionsvæske, opløsning
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Marketing authorisation number 41289 (authorised in DK)
Starting Dose
4 mL
Dose Levels
4 mL
Frequency
Single infusion over 5 minutes
Maximum Dose
4 mL

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