Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
5,204
Countries
1
Sites
4
ST-segment Elevation Myocardial Infarction
The aim of the trial is to evaluate the effect of prehospital pulse-dose glucocorticoid on all-cause mortality compared to placebo in patients with STEMI
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 20 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Sundhedsdonationer · Hjerteforeningen
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
The aim of the trial is to evaluate the effect of prehospital pulse-dose glucocorticoid on all-cause mortality compared to placebo in patients with STEMI
Secondary objectives 8
- To determine whether glucocorticoid treatment reduces cardiovascular mortality
- To determine whether glucocorticoid treatment reduces spontaneous myocardial infarction
- To determine whether glucocorticoid treatment reduces admission for heart failure
- To determine whether glucocorticoid treatment reduces all-cause mortality and admission for heart failure
- To determine whether glucocorticoid treatment reduces cardiovascular mortality and admission for heart failure
- To determine whether glucocorticoid treatment reduces recurrent non-fatal cardiovascular events (spontaneous myocardial infarction and admission for heart failure) with death as a terminal event
- To determine whether the response to glucocorticoid treatment differs in prespecified subgroups defined by age, sex, left ventricular ejection fraction <45% at arrival, anterior infarction, multivessel disease (>50% angiographic stenosis in non-culprit artery), symptom to intervention <6 hours, and thrombolysis in myocardial infarction grade 0-1 before percutaneous coronary intervention
- To determine whether glucocorticoid treatment improves prognosis in patients with STEMI and type I myocardial infarction
Conditions and MedDRA coding
ST-segment Elevation Myocardial Infarction
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | PULSE-MI2 This study is an investigator-initiated, 1:1 randomized, double-blinded, placebo-controlled clinical trial. The trial will be chaired at the Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Denmark. The study design is described in the protocol section 5.1.
|
Randomised Controlled | Double | [{"id":181160,"code":2,"name":"Investigator"},{"id":181156,"code":1,"name":"Subject"},{"id":181159,"code":4,"name":"Analyst"},{"id":181157,"code":5,"name":"Carer"},{"id":181158,"code":3,"name":"Monitor"}] | Placebo: Intravenous infusion of 4 mL isotonic NaCl (0.9%) over a period of 5 minutes 250 mg methylprednisolone: 2 x 125 mg/2 mL Solu-Medrol, a total of 250 mg/4 mL, which comes as a sterile powder with pre-servative free isotonic NaCl as diluent. The drug is infused over a period of 5 minutes. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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 3
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- All-cause mortality
Secondary endpoints 6
- Cardiovascular mortality
- Spontaneous myocardial infarction
- Admission for heart failure
- All-cause mortality or admission for heart failure
- Cardiovascular mortality or admission for heart failure
- Recurrent non-fatal cardiovascular events (spontaneous myocardial infarction and admission for heart failure) with death treated as a terminal event
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SOLU-MEDROL 125 mg pulver och vätska till injektionsvätska, lösning
PRD2076544 · Product
- Active substance
- Methylprednisolone
- Substance synonyms
- 6-METHYLPREDNISOLONE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 250 mg/g milligram(s)/gram
- Max total dose
- 250 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB04 — METHYLPREDNISOLONE
- Marketing authorisation
- 6397
- MA holder
- PFIZER OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Natriumchlorid ”Noridem”,solvens til parenteral anvendelse/injektionsvæske, opløsning
PRD388433 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 4 ml millilitre(s)
- Max total dose
- 4 ml millilitre(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 41289
- MA holder
- NORIDEM ENTERPRISES LTD
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Thomas Engstrøm
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Thomas Engstrøm
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Region Hovedstaden ORG-100003705
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 5,204 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Rigshospitalet
Heart Center, Department of Cardiology, Blegdamsvej 9, 2100, Copenhagen Oe
Aalborg University Hospital
Heart Center, Department of Cardiology, Hobrovej 18-22, 9000, Aalborg
Aarhus Universitet
Heart Center, Department of Cardiology, Palle Juul-Jensens Boulevard 11, 8200, Aarhus N
Odense University Hospital
Heart Center, Department of Cardiology, J. B. Winsloews Vej 4, 5000, Odense C
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2026-04-20 | 2026-04-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protokol PULSE-MI 2 | 2 |
| Recruitment arrangements (for publication) | Recruitment arrangements final | 3 |
| Subject information and informed consent form (for publication) | Ambulanceregistrering_redcap | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation | 3 |
| Subject information and informed consent form (for publication) | Forsgsvrgeinformation | 3 |
| Subject information and informed consent form (for publication) | Parrende- og forsgsvrgesamtykke_vek | 1 |
| Subject information and informed consent form (for publication) | Parrendeinformation | 3 |
| Subject information and informed consent form (for publication) | Patientsamtykke_vek | 1 |
| Subject information and informed consent form (for publication) | Rettigheder som forsgsperson VEK | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC - Solu-medrol | 1 |
| Synopsis of the protocol (for publication) | Trial synopsis | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-23 | Denmark | Acceptable 2026-03-09
|
2026-03-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-14 | Denmark | Acceptable 2026-03-09
|
2026-04-14 |