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

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ClinicalTrials.gov Identifier: NCT03646357
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : October 2, 2018
Sponsor:
Collaborators:
Drammen sykehus
The Hospital of Vestfold
University of Oslo
Helse Stavanger HF
Haukeland University Hospital
St. Olavs Hospital
University Hospital of North Norway
Sorlandet Hospital HF
Feiringklinikken
Information provided by (Responsible Party):
Dan Atar, Oslo University Hospital

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

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Non-ST Elevation Myocardial Infarction ST Elevation Myocardial Infarction Other: Non-betablocker Drug: Betablocker Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: PROBE - prospective, randomized, open blinded end-point
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BEtablocker Treatment After Acute Myocardial Infarction in Patients Without Reduced Left Ventricular Systolic Function (BETAMI)
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Betablocker
Patients receiving a betablocker. 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.


Experimental: Non-Betablocker
No betablocker is given to this arm. Any other treatment or management is to be given as per usual care.
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.




Primary Outcome Measures :
  1. Time to the composite of death of any cause and non-fatal myocardial infarction [ Time Frame: 2 years minimum ]
    Incidence of combined endpoint from randomization. Estimated maximal follow-up for each patient for this outcome is 1-3 years


Secondary Outcome Measures :
  1. Non-fatal MI [ Time Frame: 2 years minimum ]
    Time to non-fatal MI from randomization. Estimated maximal follow-up for each patient for this outcome is 1-3 years

  2. All-cause death [ Time Frame: 2 years minimum ]
    Time to a-cause Death from randomization. Estimated maximal follow-up for each patient for this outcome is 1-3 years

  3. Ventricular arrhythmia [ Time Frame: 2 years minimum ]
    Time to ventricular arrhythmia from randomization. Estimated maximal follow-up for each patient for this outcome is 1-3 years

  4. Hospitalization for heart failure [ Time Frame: 2 years minimum ]
    Time to hospitalization for heart failure from randomization. Estimated maximal follow-up for each patient for this outcome is 1-3 years

  5. Cardiovascular death [ Time Frame: 2 years minimum ]
    Time to cardiovascular death from randomization. Estimated maximal follow-up for each patient for this outcome is 1-3 years



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

To be eligible for inclusion in the study, subjects must fulfill the following criteria at inclusion:

  • 18 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

Exclusion Criteria

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)
  • Known hypersensitivity to any ingredient of the IMP
  • Other, according to the responsible investigator
  • End-stage somatic disease with short life expectancy, dementia, psychosis and other conditions could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible

Previous treatment with a betablocker is not an exclusion criterion for enrollment into the BETAMI study. Enrolled patients can participate in any other study that does not directly alter the effect betablocker treatment


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646357


Contacts
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Contact: John Munkhaugen, MD PhD 004732803000 johmun@vestreviken.no
Contact: Vidar Ruddox, MD PhD 004733342000 vidar.ruddox@siv.no

Locations
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Norway
Sørlandet Sykehus Recruiting
Arendal, Norway
Contact: Jarle Jortveit, PhD         
Drammen Hospital Recruiting
Drammen, Norway
Contact: John Munkhaugen, PhD       John.munkhaugen@betami.org   
AHUS Recruiting
Lørenskog, Norway
Contact: Henrik Schirmer    PhD      
Vestfold hospital Recruiting
Tønsberg, Norway
Contact: Vidar Ruddox, PhD    004733342000      
Contact: Jan Erik Otterstad, PhD    004733342662      
Sponsors and Collaborators
Oslo University Hospital
Drammen sykehus
The Hospital of Vestfold
University of Oslo
Helse Stavanger HF
Haukeland University Hospital
St. Olavs Hospital
University Hospital of North Norway
Sorlandet Hospital HF
Feiringklinikken
Investigators
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Study Chair: Dan Atar, MD Prof Oslo University Hospital
  Study Documents (Full-Text)

Documents provided by Dan Atar, Oslo University Hospital:

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Responsible Party: Dan Atar, Professor of Cardiology, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03646357     History of Changes
Other Study ID Numbers: 2018-000590-75
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dan Atar, Oslo University Hospital:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Ischemia
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Metoprolol
Bisoprolol
Betablocker
Anti-Arrhythmia Agents
Physiological Effects of Drugs
Beta-blocker
Beta blocker

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Metoprolol
Bisoprolol
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action