STem cElls Mobilization with G-CSF in patient with ventricular disfunction after a large anterior acute myocardial infarction

STEM-AMI OUTCOME TRIAL STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial - STEM-AMI Outcome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001772-38-IT

Enrollment

1530

Registered

2013-05-13

Start date

2013-06-29

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with left ventricular systolic disfunction after revascularization for acute myocardial infarction MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Zarzio Product Name: Filgrastim Product Code: Zarzio Pharmaceutical Form: Solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients affected by acute anterior STEMI undergoing primary PCI or PCI-rescue with persistent occlusion of coronary artery, Time symptom-to-balloon (=3 h and =12h or =24 h if symptoms persist), TIMI flow post PCI =2, Evidence of left ventricular dysfunction (EF biplane ?45%) =24 h after revascularization, Men and women aged =18 years and =75 years, Informed consent must be signed before proceeding with any study procedure. 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 1000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 530

Exclusion criteria

Exclusion criteria: Previous anterior MI, Recent MI (within 1 month), Known previous LV dysfunction (EF 25.000 mm3, Platelet <50.000 mm3, Sepsis, Known HIV infection, Immune system diseases, Interstitial lung disease Serious concomitant medical conditions (other than ischemic heart disease), Pregnancy and breast feeding, Documented alcohol and drug abuse, Anticipated poor compliance. Current participation in a clinical trial with other investigational products Other cell therapy.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that G-CSF therapy in addition to state of the art treatment (pharmacological and non pharmacological) is safe and significantly improves clinical outcome in patients with reduced left ventricular EF (= 45%) after successful reperfusion for anterior acute MI;Secondary Objective: Not applicable;Primary end point(s): All cause death or, recurrence of MI or, hospitalization due to heart failure. ;Timepoint(s) of evaluation of this end point: 24 months from enrolment	—

Measure

Time frame

Main Objective: To demonstrate that G-CSF therapy in addition to state of the art treatment (pharmacological and non pharmacological) is safe and significantly improves clinical outcome in patients with reduced left ventricular EF (= 45%) after successful reperfusion for anterior acute MI;Secondary Objective: Not applicable;Primary end point(s): All cause death or, recurrence of MI or, hospitalization due to heart failure. ;Timepoint(s) of evaluation of this end point: 24 months from enrolment

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy endpoints - All cause death, - recurrence of MI, - hospitalization due to heart failure, - cardiovascular death, - coronary revascularization, - fatal and non fatal stroke, - hospitalization due to any cause, - cardiovascular hospitalization, - resuscitation and/or appropriate AICD therapy. Safety endpoints - Incidence and severity of bleeding complications, - incidence of malignancy, - incidence and intensity of SAEs and ADRs. ;Timepoint(s) of evaluation of this end point: 24 months from enrolment	—

Measure

Time frame

Secondary end point(s): Efficacy endpoints - All cause death, - recurrence of MI, - hospitalization due to heart failure, - cardiovascular death, - coronary revascularization, - fatal and non fatal stroke, - hospitalization due to any cause, - cardiovascular hospitalization, - resuscitation and/or appropriate AICD therapy. Safety endpoints - Incidence and severity of bleeding complications, - incidence of malignancy, - incidence and intensity of SAEs and ADRs. ;Timepoint(s) of evaluation of this end point: 24 months from enrolment

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Countries

Italy

Contacts

Public ContactClinical Trial information

A.N.M.C.O. Fondazione Italiana Lotta malattie Cardiovascolari

centrostudi@anmco.it00390555101361

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026