BEtablocker Treatment After Acute Myocardial Infarction in Patients Without Reduced Left Ventricular Systolic Function

NCT03646357 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2895

Last updated 2025-06-08

No results posted yet for this study

Summary

The study aims to investigate whether oral betablocker (BB) therapy is superior to no such treatment following an acute myocardial infarction (AMI).

Conditions

  • Acute Myocardial Infarction
  • Non-ST Elevation Myocardial Infarction
  • ST Elevation Myocardial Infarction

Interventions

OTHER

Non-betablocker

No betablocker will be administered. Patients randomized to no beta-blockade will be discouraged to use 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.

DRUG

Betablocker

A betablocker will be administered. To reflect contemporary management, for which this study is designed to test, there will not be a defined minimum dosage. The type and dose of BB will be left at the discretion of the PI. Generic drug and accepted dosages will be: * Metoprolol succinate up to a total dose of 200mg daily * Bisoprolol up to a total dose of 10mg daily * Carvedilol up to a total dose of 50mg daily The treating physician will be encouraged to aim for an equipotent dose of 100 mg metoprolol succinate or higher. Any other treatment or management is to be given as per usual care.

Sponsors & Collaborators

  • Vestre Viken Hospital Trust

    collaborator OTHER
  • The Hospital of Vestfold

    collaborator OTHER
  • University of Oslo

    collaborator OTHER
  • Helse Stavanger HF

    collaborator OTHER_GOV
  • Haukeland University Hospital

    collaborator OTHER
  • St. Olavs Hospital

    collaborator OTHER
  • University Hospital of North Norway

    collaborator OTHER
  • Sorlandet Hospital HF

    collaborator OTHER_GOV
  • Norwegian University of Science and Technology

    collaborator OTHER
  • Sykehuset Innlandet HF

    collaborator OTHER
  • Nordlandssykehuset HF

    collaborator OTHER
  • Lovisenberg Diakonale Hospital

    collaborator OTHER
  • Diakonhjemmet Hospital

    collaborator OTHER
  • Ostfold Hospital Trust

    collaborator OTHER
  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Dan Atar, MD Prof · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2025-04-04
Completion
2035-12-10

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03646357 on ClinicalTrials.gov