BETAMI 2018.

Study name	BEtablocker Treatment After Acute Myocardial Infarction in Patients Without Reduced Left Ventricular Systolic Function (BETAMI)
Methods	Prospective, randomised, open‐blinded endpoint (PROBE) study
Participants	Patients with AMI will be randomised 1 to 8 days following PCI or thrombolysis, and will be allocated to prescription of a BB or to no such prescription. They will be followed for at least 2 years with respect to primary and secondary endpoints
Interventions	Control group: no beta‐blocker will be administered. Patients randomised to no beta‐blockade will be discouraged from using beta‐blockade as long as there is no other indication than strictly secondary prevention after myocardial infarction. Any other treatment or management is to be given as per usual care Experimental group: a beta‐blocker will be administered. To reflect contemporary management, which this study is designed to test, there will not be a defined minimum dosage. Type and dose of BB will be left to the discretion of the PI. Generic drug and accepted dosages will be: metoprolol succinate up to a total dose of 200 mg daily bisoprolol up to a total dose of 10 mg daily carvedilol up to a total dose of 50 mg daily Any other treatment or management is to be given as per usual care
Outcomes	Primary outcomes Time to the composite of death of any cause and non‐fatal myocardial infarction [Time Frame: 2 years minimum]. Incidence of combined endpoint from randomisation. Estimated maximal follow‐up for each patient for this outcome is 1 to 3 years Secondary outcomes Non‐fatal MI [Time Frame: 2 years minimum]. Time to non‐fatal MI from randomisation. Estimated maximal follow‐up for each patient for this outcome is 1 to 3 years All‐cause death [Time Frame: 2 years minimum]. Time to cause of death from randomisation. Estimated maximal follow‐up for each patient for this outcome is 1 to 3 years Ventricular arrhythmia [Time Frame: 2 years minimum]. Time to ventricular arrhythmia from randomisation. Estimated maximal follow‐up for each patient for this outcome is 1 to 3 years Hospitalisation for heart failure [Time Frame: 2 years minimum]. Time to hospitalisation for heart failure from randomisation. Estimated maximal follow‐up for each patient for this outcome is 1 to 3 years Cardiovascular death [Time Frame: 2 years minimum]. Time to cardiovascular death from randomisation. Estimated maximal follow‐up for each patient for this outcome is 1 to 3 years
Starting date	1 October 2018
Contact information	John Munkhaugen, MD, PhD; johmun@vestreviken.no Vidar Ruddox, MD, PhD; vidar.ruddox@siv.no
Notes	NCT number: NCT03646357