Completed

TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion

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What is being tested

Beta blocker

Drug
Who is being recruted

Cardiovascular Diseases+7

+ Heart Diseases

+ Infarction

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: October 2018
See protocol details

Summary

Principal SponsorFundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 31, 2018

Actual date on which the first participant was enrolled.

Pragmatic, controlled, prospective, randomized, open-label, blinded endpoint clinical trial testing the benefits of beta-blocker maintenance therapy in patients discharged after an acute myocardial infarction (MI). Patients being discharged after an acute MI, with or without ST-segment elevation, and with a left ventricular ejection fraction >40%, and without history of heart failure (HF) prior to study inclusion, will be recruited. At discharge, patients will be randomized (1:1) to receive beta-blocker therapy (agent and dose according to treating physician) or no beta-blocker therapy. Primary outcome is the 5 years incidence of MACE (all cause mortality, reinfarction, heart failure admission).

Official TitleTREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion
NCT03596385
Principal SponsorFundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

8505 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesInfarctionIschemiaMyocardial InfarctionNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial Ischemia

Criteria

4 inclusion criteria required to participate
≥18 years old
Admitted for STEMI or NSTEMI and invasive management (i.e. coronary angiography during index hospitalization).
LVEF>40% as evaluated by any imaging technique anytime during hospitalization.
Signed informed consent
7 exclusion criteria prevent from participating
Known allergy or intolerance to beta-blockers
Absolute contraindication to beta-blocker therapy according to treating physician judge
Prior history of HF, Killip class on admission or during hospitalization ≥ II
Severe valvular heart disease (> 3+ for aortic or mitral insufficiency, aortic or mitral valve area ≤1.0 cm2).
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This is a strategy (pragmatic) trial. In patients allocated to "Beta-blocker therapy", beta blocker agent and dose are decided by treating physician. betablocker therapy chosen might be any of the following: atenolol bisoprolol carvedilol metoprolol nebivolol

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 111 locations

Suspended

Azienda Ospedaliera Universitaria - Ospedali Riuniti Foggia

Foggia, ItalyOpen Azienda Ospedaliera Universitaria - Ospedali Riuniti Foggia in Google Maps
Suspended

Ospedale C.G.Morgagni

Forlì, Italy
Suspended

Ospedale Misericordia

Grosseto, Italy
Suspended

Ospedale Gualdo Tadino

Gubbio, Italy
Completed111 Study Centers
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