EUCTR2017-002485-40-IT
Active, not recruiting
Phase 1
TREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT) - REBOOT
CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III0 sites8,468 target enrollmentJanuary 15, 2021
ConditionsSTEMI or NSTEMI patients being discharged from the index hospitalization with a LVEF>40% without previous heart failureMedDRA version: 20.0Level: LLTClassification code 10021758Term: Infarct myocardialSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsMETOPROLOLO DOC GENERICI - 100 MG COMPRESSE 30 COMPRESSEATENOLOLO AHCL - 50 MG COMPRESSE 14 COMPRESSE IN BLISTER PVC/PVDC/ALBISOPROLOLO ACTAVIS - 5 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/ALCARVEDILOLO RANBAXY - 25 MG COMPRESSE 30 COMPRESSE DIVISIBILINEBIVOLOLO SANDOZ - 5 MG COMPRESSE 30 COMPRESSE IN BLISTER PVC/AL
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- STEMI or NSTEMI patients being discharged from the index hospitalization with a LVEF>40% without previous heart failure
- Sponsor
- CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III
- Enrollment
- 8468
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) \> 18 years old or 18 years old
- •2\) STEMI or STEMI patient
- •3\) LVEF \>40%
- •4\) INFORM CONSENT SIGNED
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 2000
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 6468
Exclusion Criteria
- •1\) Known allergy or intolerance to beta\-blockers
- •2\) Absolute contraindication to beta\-blocker therapy according to treating physician judge
- •3\) Prior history of HF, Killip class on admission or during hospitalization \= II
- •4\) Severe valvular heart disease (\> 3\+ for aortic or mitral insufficiency, aortic or mitral valve area \=1\.0 cm2\).
- •5\) Any condition (appart from AMI) that requires beta\-blocker prescription on discharge according to treating physician judge
- •6\) Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year),
- •7\) Patients participating in other clinical trials.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
BETAMI studien: Behandling med eller uten betablokkere hos pasientermed hjerteinfarktPatients admitted to hospital with acute myocardial infarction treated With reperfusion therapy (i.e trombolysis or percutaneous coronary intervention)Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2018-000590-75-NOOslo University Hospital5,000
Completed
Phase 4
TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion"Myocardial InfarctionNCT03596385Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III8,505
Active, not recruiting
Phase 1
Danish trial of beta blocker treatment after myocardial infarction without signs of heart failure (DANBLOCK)MedDRA version: 20.0Level: LLTClassification code 10028595Term: Myocardial infarctSystem Organ Class: 10007541 - Cardiac disordersMyocardial infarction. We wish to test whether long-term treatment with betablocker (bisoprolol, carvedilol, metoprolol or nebivolol) leads to better prognosis than no treatment in patients suffering a myocardial infarction who do not have signs of heart failureTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2018-002699-42-DKBispebjerg Frederiksberg Hospital2,760
Active, not recruiting
Phase 4
BEtablocker Treatment After Acute Myocardial Infarction in Patients Without Reduced Left Ventricular Systolic FunctionAcute Myocardial InfarctionNon-ST Elevation Myocardial InfarctionST Elevation Myocardial InfarctionNCT03646357Oslo University Hospital2,895
Active, not recruiting
Phase 1
Evaluation of Beta Blockers for the Treatment of Asthma. A randomised controlled trial of propranolol.asthmaMedDRA version: 12.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2009-017356-28-GBniversity of Dundee15