Myocardial InfarctionPhase 4NCT03596385
TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion"
A Phase 4 study testing Beta blocker in people with Myocardial Infarction, run by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III at 111 sites in 2 countries.
Trial summary
REBOOT clinical trial will study whether long-term maintenance beta-blockers therapy results in a clinical benefit after heart attack without reduced left ventricular function. Half of the participants will be randomized to receive long-term beta-blocker therapy and the other half to no beta-blocker therapy after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Beta blocker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,505 participants
- Where
- 111 sitesin 2 countries
- Study dates
- 31 Oct 2018to 31 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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).
- Any condition (appart from AMI) that requires beta-blocker prescription on discharge according to treating physician judge
- Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year),
- Patients participating in other clinical trials
Trial locations and contacts
111 sites in 2 countries.
111 sites in 2 countries
Spain75 sites
Complejo hospitalario universitario a Coruña
A Coruña
Txagorritxu
Alava
Fundacion Alcorcon
Alcorcón
Virgen de los Lirios de Alcoy
Alcoy
H. San Juan
Alicante
Hospital Alto del Gualdalquivir
Andújar
San Agustin
Avilés
Centro Medico Teknon
Barcelona
Clinic
Barcelona
Consorci Sanitari Integral
Barcelona
Germans Trias i Pujol
Barcelona
H. Vall d´Hebron
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitario de Bellvitge
Barcelona
Hospital de Basurto
Bilbao
Hospital Universitario de Burgos
Burgos
H. Santa Lucía
Cartagena
Hosptial Universitario Reina Sofia
Córdoba
Hospital de Denia
Denia
Hospital universitario de Elche
Elche
Hospital Universitario de Vinalopo
Elche
H.Universitario de Elda
Elda
Hospital Arquitecto Macide
Ferrol
Hospital Galdakao Usansolo
Galdakao
Cabueñes
Gijón
Hospital San Cecilio
Granada
Hospital Virgen de las Nieves
Granada
H.U Juan Ramón Jimenez
Huelva
Complejo Hospitalario Universitario de Jaen
Jaén
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria
Hospital de Leon
León
Hospital Universitario de Arnau de Vilanova
Lleida
Lucus Augusti
Lugo
Fundación Jiménez Díaz University Hospital
Madrid, Madrid, 28040
Clinica La Luz
Madrid
CNIC
Madrid
Hospital 12 de Octubre
Madrid
Hospital Clinico
Madrid
Hospital Gregorio Marañon
Madrid
Hospital Quirón Pozuelo
Madrid
Ruber Internacional
Madrid
Ruber Juan Bravo
Madrid
Hospital regional Universitario de Malaga
Málaga
Hospital de Manresa
Manresa
Hospital Alvarez Buylla
Mieres
Rey Juan Carlos
Móstoles
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia
Hospital Universitario Central Asturias
Oviedo
Son Espases
Palma de Mallorca
Complejo Hospitalario de Navarra
Pamplona
Montecelo
Pontevedra
Clinico Universitario de Salamanca
Salamanca
Complejo hospitalario Universitario de Canarias
Santa Cruz de Tenerife
Hospital General de La Palma
Santa Cruz de Tenerife
Nuestra Señora de la Candelaria
Santa Cruz de Tenerife
Marques de Valdecilla
Santander
Complejo hospitalario universitario de Santiago
Santiago de Compostela
H. Virgen del Rocio
Seville
Virgen de la Macarena
Seville
Hospital Universitari Joan XXIII
Tarragona
Hospital Universitario Sant Joan de Reus
Tarragona
Hospital Universitario de Torrejon
Torrejón de Ardoz
Hospital Universitario de Torrevieja
Torrevieja
H. Verge de la Cinta
Tortosa
San Juan de la Cruz
Úbeda
Hospital Infanta Elena
Valdemoro
Hospital Clinico
Valencia
Hospital La Fe
Valencia
Hospital universitario doctor Peset
Valencia
IMED Valencia
Valencia
Hospital Clinico universitario de Valladolid
Valladolid
Río Hortega
Valladolid
Alvaro Cunqueiro
Vigo
Hospital General de Villalba
Villalba
Miguel Servet
Zaragoza
Italy36 sites
Ospedale Civile Santi Antonio e Biagio
Alessandria
Azienda Ospedaliero Universitaria Ospedali Riuniti
Ancona
Ospedale Civile
Baggiovara
Istituto Maugeri IRCCS
Bari
Ospedale San Paolo
Bari
Ospedale Maggiore
Bologna
A.O. Sant'Anna e San Sebastiano di Caserta
Caserta
Santa Margherita
Cortona
Ospedale di Cremona
Cremona
Ospedale di Desio
Desio
Ospedale San Giuseppe
Empoli
Ospedale di Vaio
Fidenza
Azienda Ospedaliera Universitaria - Ospedali Riuniti Foggia
Foggia
Ospedale C.G.Morgagni
Forlì
Ospedale Misericordia
Grosseto
Ospedale Gualdo Tadino
Gubbio
Ospedale Civile di Legnano
Legnano
Ospedale di Vizzolo Predabissi
Melegnano
Mario Negri
Milan
Ospedale San Paolo
Milan
Ospedale Sacro Cuore Don Calabria
Negrar
Ospedale San Luigi Gonzaga
Orbassano
Policlinico San Marco
Osio Sotto
Villa Sofía, Palermo
Palermo
P.O. di Passirana
Passirana
Ospedale G. da Saliceto ,Piacenza
Piacenza
Ospedalel Santa Maria delle Croci
Ravenna
Arcispedale S. Maria Nuova
Reggio Emilia
Ospedale Infermi di Rimini
Rimini
San Filippo Neri
Roma
Teresa Masselli Mascia
San Severo, Foggia
Presidio Ospedaliero di Saronno
Saronno
Ospedale Veris Delli Ponti
Scorrano
Ospedale Bolognini
Seriate
Ospedale di Treviglio
Treviglio
Ospedale di Udine
Udine
About this study
Official title: TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion
REBOOT clinical trial will study whether long-term maintenance beta-blockers therapy results in a clinical benefit after heart attack without reduced left ventricular function. Half of the participants will be randomized to receive long-term beta-blocker therapy and the other half to no beta-blocker therapy after hospital discharge. All patients will be followed up for up to 5 years to determine the occurrence of adverse events (all cause mortality, re-infarction, and heart failure admission).
Read the detailed description
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).
- Conditions
- Myocardial Infarction
- Being tested
- Beta blocker
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta blockerDrug
Also called atenolol, bisoprolol, carvedilol, metoprolol, nevibolol.
long-term maintenance beta-blocker therapy
| Study group | Role | What they receive |
|---|---|---|
| Beta-blocker therapy | 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 Receives: Drug: Beta blocker |
| Control (no beta-blocker therapy). | No intervention | Do not receive beta -blocker therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of the composite of "all-cause death, nonfatal reinfarction, or heart failure hospitalization" (MACE)
absolute number of patients experiencing deaths will be added to number of patients experiencing a non fatal reinfarction and to number of patients experiencing heart failure hospitalization.
If a patient experience more than one of these events, only first event will be added for the sum of events
EXAMPLE events in arm 1: 150 deaths+150 reinfarctions+150 heart failure hospitalizations= TOTAL 450 MACE (450 events/4234 patients enroled: event rate 10.63%)
Measured: 12-54 months since the beginning (median follow up anticipated 3.75 years)
Secondary outcomes (1)
2.1 Incidence rate of individual components of the primary outcome. 2.2 Incidence rate of cardiac mortality. 2.3 Incidence of sustained ventricular tachycardia/ventricular fibrillation (VT/VF) and resuscitated cardiac arrest.
Absolute number of events (% from total patients recruited) of the components of the MACE (eg number of all cause deaths (% from patients included) in active arm vs control).
First event of each individual component counts for secondary outcome.
EXAMPLE all cause death events in in arm 1: 200 deaths (200 events/4234 patients enroled: event rate 4.72%).
nonfatal reinfarctions in in arm 1: 150 reinfarctions (150 events/4234 patients enroled: event rate 3.54%).
note that in the example of the primary outcome, only 150 deaths are counted and for the secondary outcome 200. This is because in this hypothetical case, 50 deaths occurred in patients who previously experienced a nonfatal reinfarction
Measured: 12-54 months since the beginning (median follow up anticipated 3.75 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start31 Oct 2018
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Borja Ibañez, MD PhD FESC, Principal investigator, CNIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596385
- Sponsor's protocol ID
- REBOOT-CNIC
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2018
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rossello X, Raposeiras-Roubin S, Latini R, Dominguez-Rodriguez A, Barrabes JA, Sanchez PL, Anguita M, Fernandez-Vazquez F, Pascual-Figal D, De la Torre Hernandez JM, Ferraro S, Vetrano A, Perez-Rivera JA, Prada-Delgado O, Escalera N, Staszewsky L, Pizarro G, Aguero J, Pocock S, Ottani F, Fuster V, Ibanez B; REBOOT-CNIC investigators. Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT). Eur Heart J Cardiovasc Pharmacother. 2022 May 5;8(3):291-301. doi: 10.1093/ehjcvp/pvab060.
PubMed 34351426Raposeiras-Roubin S, Anguita M, Latini R, Dominguez-Rodriguez A, Barrabes JA, Sanchez PL, Ottani F, Pocock S, Owen R, Cristobo P, Gomez-Talavera S, Staszewsky L, Escalera N, Fernandez-Vazquez F, Bianco M, Prada-Delgado O, Perez-Garcia CN, Pelizzoni V, Navarro F, Perez-Rivera JA, Martin-Gorria G, Vetrano A, Fuster V, Rossello X, Ibanez B. Beta-blockers after invasively managed STEMI vs NSTEMI without reduced ejection fraction: a prespecified analysis from the REBOOT trial. Rev Esp Cardiol (Engl Ed). 2026 Apr 23:S1885-5857(26)00076-9. doi: 10.1016/j.rec.2026.03.007. Online ahead of print. English, Spanish.
PubMed 42034335Ibanez B, Latini R, Rossello X, Dominguez-Rodriguez A, Fernandez-Vazquez F, Pelizzoni V, Sanchez PL, Anguita M, Barrabes JA, Raposeiras-Roubin S, Pocock S, Escalera N, Staszewsky L, Perez-Garcia CN, Diez-Villanueva P, Perez-Rivera JA, Prada-Delgado O, Owen R, Pizarro G, Caldes O, Gomez-Talavera S, Tunon J, Bianco M, Zarauza J, Vetrano A, Campos A, Martinez-Huertas S, Bueno H, Puentes M, Grigis G, Bonilla-Palomas JL, Marco E, Gonzalez-Juanatey JR, Bangueses R, Gonzalez-Juanatey C, Garcia-Alvarez A, Ruiz-Garcia J, Carrasquer A, Garcia-Rubira JC, Pascual-Figal D, Tomas-Querol C, San Roman JA, Baratta P, Aguero J, Martin-Reyes R, Colivicchi F, Ortas-Nadal R, Bazal P, Cordero A, Fernandez-Ortiz A, Basso P, Gonzalez E, Poletti F, Bugani G, Debiasio M, Cosmi D, Navazio A, Bermejo J, Tortorella G, Marini M, Botas J, de la Torre-Hernandez JM, Ottani F, Fuster V; REBOOT-CNIC Investigators. Beta-Blockers after Myocardial Infarction without Reduced Ejection Fraction. N Engl J Med. 2025 Nov 13;393(19):1889-1900. doi: 10.1056/NEJMoa2504735. Epub 2025 Aug 30.
PubMed 40888702Granger 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.
PubMed 36526898
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion
- ClinicalTrials.gov ID
- NCT03596385
- Acronym / sponsor ID
- REBOOT-CNIC
- Conditions
- Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,505 participants (actual)
- Lead sponsor
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos IIIUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
REBOOT clinical trial will study whether long-term maintenance beta-blockers therapy results in a clinical benefit after heart attack without reduced left ventricular function. Half of the participants will be randomized to receive long-term beta-blocker therapy and the other half to no beta-blocker therapy after hospital discharge. All patients will be followed up for up to 5 years to determine the occurrence of adverse events (all cause mortality, re-infarction, and heart failure admission).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-blocker therapy | Experimental | Drug: Beta blockerThis 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 |
| Control (no beta-blocker therapy). | No intervention | –Do not receive beta -blocker therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (7 listed)
- 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).
- Any condition (appart from AMI) that requires beta-blocker prescription on discharge according to treating physician judge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta blockerAlso: atenolol, bisoprolol, carvedilol, metoprolol, nevibolol.long-term maintenance beta-blocker therapy | Drug | Beta-blocker therapy |
Primary outcome
Incidence rate of the composite of "all-cause death, nonfatal reinfarction, or heart failure hospitalization" (MACE)
Time frame: 12-54 months since the beginning (median follow up anticipated 3.75 years)
absolute number of patients experiencing deaths will be added to number of patients experiencing a non fatal reinfarction and to number of patients experiencing heart failure hospitalization. If a patient experience more than one of these events, only first event will be added for the sum of events EXAMPLE events in arm 1: 150 deaths+150 reinfarctions+150 heart failure hospitalizations= TOTAL 450 MACE (450 events/4234 patients enroled: event rate 10.63%)
1 secondary outcome
2.1 Incidence rate of individual components of the primary outcome. 2.2 Incidence rate of cardiac mortality. 2.3 Incidence of sustained ventricular tachycardia/ventricular fibrillation (VT/VF) and resuscitated cardiac arrest.
Time frame: 12-54 months since the beginning (median follow up anticipated 3.75 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 34351426Rossello X, Raposeiras-Roubin S, Latini R, Dominguez-Rodriguez A, Barrabes JA, Sanchez PL, Anguita M, Fernandez-Vazquez F, Pascual-Figal D, De la Torre Hernandez JM, Ferraro S, Vetrano A, Perez-Rivera JA, Prada-Delgado O, Escalera N, Staszewsky L, Pizarro G, Aguero J, Pocock S, Ottani F, Fuster V, Ibanez B; REBOOT-CNIC investigators. Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT). Eur Heart J Cardiovasc Pharmacother. 2022 May 5;8(3):291-301. doi: 10.1093/ehjcvp/pvab060.
- Derived from this study: PubMed 42034335Raposeiras-Roubin S, Anguita M, Latini R, Dominguez-Rodriguez A, Barrabes JA, Sanchez PL, Ottani F, Pocock S, Owen R, Cristobo P, Gomez-Talavera S, Staszewsky L, Escalera N, Fernandez-Vazquez F, Bianco M, Prada-Delgado O, Perez-Garcia CN, Pelizzoni V, Navarro F, Perez-Rivera JA, Martin-Gorria G, Vetrano A, Fuster V, Rossello X, Ibanez B. Beta-blockers after invasively managed STEMI vs NSTEMI without reduced ejection fraction: a prespecified analysis from the REBOOT trial. Rev Esp Cardiol (Engl Ed). 2026 Apr 23:S1885-5857(26)00076-9. doi: 10.1016/j.rec.2026.03.007. Online ahead of print. English, Spanish.
- Derived from this study: PubMed 40888702Ibanez B, Latini R, Rossello X, Dominguez-Rodriguez A, Fernandez-Vazquez F, Pelizzoni V, Sanchez PL, Anguita M, Barrabes JA, Raposeiras-Roubin S, Pocock S, Escalera N, Staszewsky L, Perez-Garcia CN, Diez-Villanueva P, Perez-Rivera JA, Prada-Delgado O, Owen R, Pizarro G, Caldes O, Gomez-Talavera S, Tunon J, Bianco M, Zarauza J, Vetrano A, Campos A, Martinez-Huertas S, Bueno H, Puentes M, Grigis G, Bonilla-Palomas JL, Marco E, Gonzalez-Juanatey JR, Bangueses R, Gonzalez-Juanatey C, Garcia-Alvarez A, Ruiz-Garcia J, Carrasquer A, Garcia-Rubira JC, Pascual-Figal D, Tomas-Querol C, San Roman JA, Baratta P, Aguero J, Martin-Reyes R, Colivicchi F, Ortas-Nadal R, Bazal P, Cordero A, Fernandez-Ortiz A, Basso P, Gonzalez E, Poletti F, Bugani G, Debiasio M, Cosmi D, Navazio A, Bermejo J, Tortorella G, Marini M, Botas J, de la Torre-Hernandez JM, Ottani F, Fuster V; REBOOT-CNIC Investigators. Beta-Blockers after Myocardial Infarction without Reduced Ejection Fraction. N Engl J Med. 2025 Nov 13;393(19):1889-1900. doi: 10.1056/NEJMoa2504735. Epub 2025 Aug 30.
- Derived from this study: PubMed 36526898Granger 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.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Borja Ibañez, MD PhD FESC principal investigator
CNIC
111 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta blocker in people with Myocardial Infarction, run by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III at 111 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 111 sites in Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of the composite of "all-cause death, nonfatal reinfarction, or heart failure hospitalization" (MACE) (time frame: 12-54 months since the beginning (median follow up anticipated 3.75 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03596385, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.