Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 80Years
All Genders
NCT07380919

Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON Study

Led by Federico II University · Updated on 2026-03-11

100

Participants Needed

3

Research Sites

17 weeks

Total Duration

On this page

Sponsors

F

Federico II University

Lead Sponsor

U

Università Magna Grecia, Catanzaro

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a Phase IIb, multicentric, prospective, randomized (1:1 ratio), open label, and no profit study, with the aim of evaluating the efficacy of late INa current inhibition to improve coronary microcirculation in patients presenting with acute myocardial infarction and multivessel disease. All consecutive patients presenting with acute MI undergoing primary PCI (pPCI) on a major coronary artery, and with at least one remaining angiographically significant (% diameter stenosis \> 50%) non-culprit stenosis will be enrolled. The primary objective of the study is to evaluate the potential effect of Ranolazine in preserving coronary microcirculation subtended to the culprit vessel as compared with control group. Coronary microcirculation will be assessed both at the time of the culprit lesion revascularization and within 6+/-2 weeks by measuring the Index of Microcirculatory Resistance (IMR) either invasively or derived by the angiography (angioIMR). In addition, the following secondary endpoints will be assessed: 1. The prevalence of residual CMD downstream to the culprit vessel in all patients (CMDculprit). CMDculprit will be defined as the finding of an IMR/angioIMR value \> 25, assessed after successful pPCI. 2\. The prevalence of CMD downstream to the non-culprit vessel in the two group of patients (CMDnon-culprit). CMDnon-culprit will be defined as the finding of an IMRnon-culprit or an angioIMRnon-culprit value \> 25. IMRnon-culprit or angioIMRnon-culprit will be assessed at the time of staged PCI of the non-culprit stenosis. 3\. The incidence of peri-procedural CMD after staged PCI of the non-culprit stenoses, defined as a 20% increase of IMR values assessed before and after elective PCI of the non-culprit vessel (CMDprocedural). 4\. The difference between the two groups of patients, in terms of incidence of periprocedural Myocardial Infarction (PMI), eventually occurring during the staged procedure. 5\. The effects of INa current inhibition on endothelial function assessed at follow up as compared with control group. 6\. The extent of the Infarct Size, as assessed by the CMR, as compared with control group. 7\. The incidence of MACE, defined as composite of death, myocardial infarction, periprocedural MI, or any unplanned percutaneous coronary revascularization at short (42+/-7 days) term follow-up. 8\. Angina symptoms and quality of life

CONDITIONS

Official Title

Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON Study

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and less than 80 years at consent
  • Ability to provide written informed consent within 1 day after successful pPCI
  • Diagnosis of ST-Elevation Myocardial Infarction (STEMI) during current hospital stay
  • Successful primary percutaneous coronary intervention (TIMI flow 3 and less than 30% residual stenosis)
  • At least one remaining significant non-culprit coronary artery stenosis over 50% suitable for PCI
  • Post-menopausal status or negative pregnancy test for women of child-bearing potential
  • Agreement to use contraception for sexually active women of child-bearing potential
Not Eligible

You will not qualify if you...

  • Hemodynamically unstable patients
  • Previous myocardial infarction
  • Previous coronary artery bypass graft surgery
  • Positive pregnancy test at enrollment or before study medication
  • Pregnant, breastfeeding, or unwilling to use birth control for women of reproductive potential
  • Known allergy to ranolazine or its ingredients
  • Chronic kidney disease stage 4 or 5 (eGFR less than 30 mL/min/1.73 m2)
  • Moderate to severe liver failure (Child Pugh B or C)
  • Use of strong CYP3A4 inhibitors, HIV protease inhibitors, or certain antiarrhythmic drugs
  • Participation in another clinical trial with investigational drug within 30 days or 5 half-lives of study drug

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Department of Medical and Surgical Sciences and "Renato Dulbecco" University Hospital, "Magna Graecia" University

Catanzaro, Italy, Italy, 88100

Actively Recruiting

2

Department of Cardiology, Santa Maria Goretti Hospital, Latina, Italy

Latina, Italy, Italy

Not Yet Recruiting

3

Federico II University Hospital - Division of Cardiology

Naples, Italy

Actively Recruiting

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Research Team

L

Luigi Di Serafino, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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