RIGENERA 2.0 Trial

• Status: Suspended
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Study Objectives: To determine whether, in patients with large acute myocardial infarction undergoing primary or rescue angioplasty, the administration of subcutaneous Lenograstim [recombinant human Granulocyte-Colony Stimulating Factor (rhu G-CSF), Myelostim 34, Italfarmaco] associated with Myocardial Contrast Echocardiography and the intravenous infusion of sulphur hexafluoride (Sonovue, Bracco) determines an improvement:

• in regional and global contractile function, myocardial perfusion and infarct size assessed by cardiovascular magnetic resonance.

• Echocardiographic parameters of LV function

• in the serum profile of inflammatory and mobilizing cytokines and of biomarkers of myocardial damage and wall stress

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Treatments: Lenograstim; Sargramostim

Criteria

Population Adult male or female patients aged < 80 years with acute myocardial infarction undergoing successful primary or rescue percutaneous recanalization of the infarct-related coronary artery, defined as TIMI 3 flow and residual stenosis <20%) within 24 hours of symptom onset and Left Ventricular Ejection Fraction (LVEF) ≤ 45% at 3-6 after revascularization, as documented by a two-dimensional echocardiogram.

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.

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