d

Phase 1

• Conditions: acute myocardial infarction; MedDRA version: 20.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002189-21-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-27
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Signed and dated informed consent
2. Men and women of any ethnic origin aged = 18 years
3. Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI.
4. Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow =2) within 24 hours of symptom onset by successful percutaneous coronary intervention (PCI) or thrombolysis within 12 hours of symptom onset followed by successful PCI within 24 hours after thrombolysis
5. Left ventricular ejection fraction = 45% at 24 hours after revascularization, as documented by a two-dimensional echocardiogram.

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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1.Participation in another clinical trial within 30 days prior to randomisation
2.Pregnant or nursing women or women in childbearing age not able to esclude the possibility of a pregnancy
3.Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
4.Necessity to revascularise additional vessels, outside the target coronary artery after investigational therapy/placebo administration (additional revascularisations after primary PCI and before investigational therapy/placebo administration are allowed)
5.Persistent cardiogenic shock
6.Known hematologic and neoplastic diseases
7.Severe impaired renal function, i.e. GFR<30 ml/min
8.Persistent fever or diarrhoea not responsive to treatment within 4 weeks prior screening or severe infection
9.Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)
10.Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified