NCT03646357

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,895

participants targeted

Target at P75+ for phase_4

Timeline
116mo left

Started Oct 2018

Longer than P75 for phase_4

Geographic Reach
1 country

20 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Oct 2018Dec 2035

First Submitted

Initial submission to the registry

May 14, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2025

Completed
10.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2035

Expected
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

6.5 years

First QC Date

May 14, 2018

Last Update Submit

June 4, 2025

Conditions

Acute Myocardial InfarctionNon-ST Elevation Myocardial InfarctionST Elevation Myocardial Infarction

Keywords

InfarctionMyocardial InfarctionST Elevation Myocardial InfarctionNon-ST Elevated Myocardial InfarctionIschemiaMyocardial IschemiaHeart DiseasesCardiovascular DiseasesMetoprololBisoprololBetablockerAnti-Arrhythmia AgentsPhysiological Effects of DrugsBeta-blockerBeta blocker

Outcome Measures

Primary Outcomes (1)

  • A composite of death of any cause, recurrent myocardial infarction, incident heart failure, coronary revascularization, ischemic stroke, malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin

    Incidence of combined endpoint from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years

    6 months (minimum) to 6 years (maximum)

Secondary Outcomes (18)

  • Recurrent MI

    6 months (minimum) to 6 years (maximum)

  • All-cause death

    6 months (minimum) to 6 years (maximum)

  • Malignant ventricular arrhythmias including resuscitated cardiac arrest of cardiac origin

    6 months (minimum) to 6 years (maximum)

  • Hospitalization or outpatient consultation for incident heart failure

    6 months (minimum) to 6 years (maximum)

  • Unplanned coronary revascularization

    6 months (minimum) to 6 years (maximum)

  • +13 more secondary outcomes

Study Arms (2)

Betablocker

ACTIVE COMPARATOR

Patients receiving a betablocker. Any other treatment or management is to be given as per usual care.

Drug: Betablocker

Non-Betablocker

EXPERIMENTAL

No betablocker is given to this arm. Any other treatment or management is to be given as per usual care.

Other: Non-betablocker

Interventions

Non-betablockerOTHER

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.

Non-Betablocker
BetablockerDRUG

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.

Betablocker

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Diagnosed with an acute MI type I according to the "Universal Definition of MI" (Defined as a detection of a rise and/or fall of cardiac biomarker value, preferably troponin, with at least one value above the 99th percentile upper reference limit and with at least one of the following; a) symptoms of ischemia, b) new or presumed new significant ST-segment-T wave changes or new left bundle branch block, c) development of pathological Q waves, d) imaging evidence of new loss of viable myocardium or e) identification of an intracoronary thrombus by coronary angiogram)
  • Must have been treated with PCI or thrombolysis during current hospitalization
  • Signed informed consent and expected cooperation of the patient according to ICH/GCP and national/local regulations
  • Have a national personal identification number and not be expected to emigrate during study

You may not qualify if:

  • Study subjects must not meet any of the following criteria:
  • Having a condition where betablocker-therapy is required, including but not limited to:
  • Arrhythmias
  • Hypertension
  • Cardiomyopathies
  • Clinical diagnosis of heart failure
  • LVEF \< 40% by echocardiography (by measurement and not only visual assessment for STEMI patients)
  • Left ventricular akinesia in ≥ 3 segments regardless of the LVEF
  • Contraindications to betablocker-therapy, including but not limited to:
  • Bradyarrhythmias
  • Hypotension
  • Severe peripheral artery disease
  • Previously known side-effects causing withdrawal
  • Severe chronic obstructive pulmonary disease
  • Women of childbearing potential (a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Sørlandet Sykehus

Arendal, Norway

Location

Haukeland Universitetssykehus

Bergen, Norway

Location

Nordlandssykehuset HF Bodø

Bodø, Norway

Location

Drammen Hospital

Drammen, Norway

Location

Sykehuset Østfold Kalnes

Fredrikstad, Norway

Location

Sykehuset Innlandet HF, Gjøvik Sykehus

Gjøvik, Norway

Location

Sykehuset Innlandet Hamar

Hamar, Norway

Location

Vestre Viken HF, Ringerike Sykehus

Hønefoss, Norway

Location

Sykehuset Innlandet Lillehammer

Lillehammer, Norway

Location

AHUS

Lørenskog, Norway

Location

LHL Gardermoen

Lørenskog, Norway

Location

Diakonhjemmet Sykehus

Oslo, Norway

Location

Lovisenberg Diakonale Sykehus

Oslo, Norway

Location

Oslo University Hospital Rikshospitalet, Dept.of Cardiology

Oslo, Norway

Location

Oslo University Hospital Ullevaal, Dept. of Cardiology

Oslo, Norway

Location

Vestre Viken HF, Bærum Sykehus

Sandvika, Norway

Location

Stavanger Universitetssjukehus

Stavanger, Norway

Location

Universitetssykehuset Nord-Norge, UNN

Tromsø, Norway

Location

St. Olavs University Hospital

Trondheim, Norway

Location

Vestfold hospital

Tønsberg, Norway

Location

Related Publications (2)

  • Munkhaugen J, Kristensen AMD, Halvorsen S, Holmager T, Olsen MH, Bakken A, Sehested TSG, Ruddox V, Maeng M, Vikenes K, Jensen SE, Steigen T, Lambrechtsen J, Jortveit J, Bovin A, Schirmer H, Christiansen MK, Wiseth R, Mikkelsen D, Larsen AI, Lyngby Kjaergaard C, Andresen K, Gustafsson I, Tuseth V, Larsen ML, Deeg PS, Veien K, Bohmer E, Botker HE, Brattrud AO, Bronnum-Schou J, Pettersen AR, Bang LE, Oie E, Engstrom T, Borg EB, Kristensen K, Nymo SH, Gislason G, Vethe NT, Abdulla JAM, Dammen T, Mouridsen MR, Bendz B, Bertelsen MLN, Hove JD, Schierbeck L, Snoer M, Davidsen C, Egholm G, Thomsen KK, Jadou G, Poenaru M, Krarup NT, Bottcher M, Staehr PB, Zwisler AD, Edvardsen T, Torp-Pedersen C, Otterstad JE, Lange T, Fagerland MW, Atar D, Prescott E; BETAMI-DANBLOCK Investigators. Beta-Blockers after Myocardial Infarction in Patients without Heart Failure. N Engl J Med. 2025 Nov 13;393(19):1901-1911. doi: 10.1056/NEJMoa2505985. Epub 2025 Aug 30.

    PMID: 40888716DERIVED

  • Granger CB, Pocock SJ, Gersh BJ. The need for new clinical trials of old cardiovascular drugs. Nat Rev Cardiol. 2023 Feb;20(2):71-72. doi: 10.1038/s41569-022-00819-1. No abstract available.

    PMID: 36526898DERIVED

MeSH Terms

Conditions

Non-ST Elevated Myocardial InfarctionST Elevation Myocardial InfarctionInfarctionMyocardial InfarctionIschemiaMyocardial IschemiaHeart DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Dan Atar, MD Prof

    Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: PROBE - prospective, randomized, open blinded end-point
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology

Study Record Dates

First Submitted

May 14, 2018

First Posted

August 24, 2018

Study Start

October 1, 2018

Primary Completion

April 4, 2025

Study Completion (Estimated)

December 10, 2035

Last Updated

June 8, 2025

Record last verified: 2025-06

Locations

NO(20)