Summary

The aim of this nationwide trial is to evaluate the effect of prehospital pulse-dose glucocorticoid on all-cause mortality compared with placebo in patients with STEMI

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Interventions 

Patients will be randomized 1:1 in the prehospital setting to either:

1. Glucocorticoid (250 mg methylprednisolone)

2. Placebo (0.9% NaCl)

Both glucocorticoid and placebo will be administered over a period of 5 minutes during transportation. All subsequent care including primary PCI, antithrombotic therapy, and guideline-based follow-up treatment will be performed according to standard clinical practice.

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Blinding 

The trial is blinded for patients, prehospital personel and physicians performing subsequent care. 

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Ethical considerations 

The study will be approved by the ethics committee, registered with the Danish Data Protection Agency, conducted according to the Declaration of Helsinki, and monitored by local GCP-units.

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Due to the emergency nature of STEMI, treatment will be initiated before consent; informed consent will be obtained as soon as possible after PCI, with representative consent used when required, following established practice in comparable acute trials. The intervention poses minimal risk, does not delay standard care, and may provide clinical benefit.

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