AzTrials
AzTrials

STEMI (ST Elevation MI)Phase 2/3INaMICRONNCT07380919

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

A Phase 2/3 study testing Ranolazine in people with STEMI (ST Elevation MI), run by Federico II University at 3 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
STEMI (ST Elevation MI)
What is being tested?
Ranolazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesItaly
Study dates
Feb 2026to Jun 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years and < 80 years on day of signing informed consent
  • Ability to provide written informed consent in a time window 0 to 1 day after successful pPCI
  • ST-Elevation Myocardial Infarction at the time of the index hospitalization.
  • Successful pPCI (Thrombolysis In Myocardial Infarction [TIMI] flow 3 and residual coronary stenosis <30%)
  • Presence of at least one remaining angiographically significant (% diameter stenosis > 50%) non-culprit stenosis treatable with PCI
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for child-bearing potential patients (definitions reported in section 10.9)
  • Agreement for child-bearing potential patients who are sexually active to use contraception (definitions reported in section 10.10)

Who cannot join

  • Hemodynamically unstable patients
  • Previous myocardial infarction
  • Previous coronary artery by-pass graft (CABG)
  • Female patients with a positive pregnancy test at enrollment or prior to administration of study medication.
  • Female patients who are pregnant or breastfeeding or reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of Ranolazine
  • Known hypersensitivity to the active principle (Ranolazine) or any of the excipients
Show all 10Show fewer
  • Chronic Kidney Disease Stage 4 or 5 (eGFR < 30 mL/min/1.73 m 2)
  • Moderate to severe liver failure (Child Pugh B - C)
  • Simultaneous intake of the following classes of drugs: strong CYP3A4 inhibitors (i.e. clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole); HIV protease inhibitors (i.e. saquinavir, indinavir, ritonavir); class Ia antiarrhythmic drugs (i.e. ajmaline, disopyramide, procainamide, quinidine ) and class III antiarrhythmic drugs except amiodarone (i.e. dofetilide, sotalol)
  • Previous participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Luigi Di Serafino, Professor contact

+390817462235

luigi.diserafino@unina.it

Italy3 sites, 3 recruiting

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

    Catanzaro, Italy, 88100

    Salvatore De Rosa, Full Professor, 0961/3697123, saderosa@unicz.it

    Recruiting

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

    Latina, Italy

    Marco Bernardi, MD, ‪+39 334 841 0722‬, marco.bernardi23@gmail.com

    Not yet recruiting

  • Federico II University Hospital - Division of Cardiology

    Naples

    Alessandra Spinelli, MSc, +39081676540, aless.spinelli@gmail.com

    Stefano Cristiano, MSc, +39081676540, stefano.cristiano@unina.it

    Recruiting

Other trials in Italy

About this study

Official title: Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: A Multicenter, Randomized, Controlled and Open Label Study (INaMICRON Study)

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.

Read more

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.

  1. 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.
  2. 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).
  3. The difference between the two groups of patients, in terms of incidence of periprocedural Myocardial Infarction (PMI), eventually occurring during the staged procedure.
  4. The effects of INa current inhibition on endothelial function assessed at follow up as compared with control group.
  5. The extent of the Infarct Size, as assessed by the CMR, as compared with control group.
  6. 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.
  7. Angina symptoms and quality of life
Read the detailed description

Ranolazine has already been studied in the setting of the acute coronary syndromes, without any significant advantage in terms of MACE occurrence as compared with control group. However, it was not associated with any significant adverse event, thereby the use of ranolazine is not forbidden in ACS patients, especially in the setting of patients with MVD. Of note, the individual component of recurrent ischemia was significantly reduced by ranolazine, as compared with control group and ranolazine reduced recurrent ischemic events, regardless of whether patients did or did not receive PCI within 30 days of a non-ST-segment ACS.

The aim of the present multicenter, randomized, controlled and open-label study is to evaluate the efficacy of late INa current inhibition to preserve coronary microcirculation after the acute myocardial infarction in patients presenting with STEMI and multivessel disease. Thereby, primary endpoint will be the relative difference in terms of IMR and/or angioIMR will be evaluated. IMR and/or angioIMR will be assessed both at the baseline (after successful coronary revascularization) and at the time of staged revascularization of the non-culprit stenosis (either at 5+/-2 days or within 6+/-2 weeks after pPCI).

In addition, as secondary objectives, It will be assessed whether the late INa current inhibition, as compared with the control group, might be effective at:

  1. Reducing the prevalence of CMD after successful pPCI
  2. Reducing the extension of the infarct size, as assessed at the cardiac magnetic resonance
  3. Reducing the prevalence of CMD downstream to the non-culprit vessel before staged PCI
  4. Reducing the incidence of CMD downstream to the non-culprit vessel after staged PCI
  5. Reducing the incidence of periprocedural MI eventually occurring after staged procedures
  6. Reducing the incidence of endothelial dysfunction
  7. Reducing the early incidence of major cardiovascular events (MACE)
  8. Improving residual angina symptoms and quality of life

Thereby, the following secondary endpoints will be evaluated:

  1. The prevalence of residual CMD downstream to the culprit vessel in the two group of patients. Residual CMD will be defined as the finding of an IMRculprit or angioIMRculprit value > 25
  2. The extent of the Infarct Size, as assessed by the CMR, in terms of grams (g) and percentage as compared with control group.
  3. 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 angioIMRnon-culprit value > 25
  4. The incidence of peri-procedural CMD after staged PCI of the non-culprit stenoses, defined as a 20% increase of IMRnon-culprit or angioIMRnon-culprit values assessed before and after elective PCI of the non-culprit vessel.
  5. The difference between the two groups of patients, in terms of incidence of periprocedural Myocardial Infarction (PMI), eventually occurring during the staged procedure. PMI require to satisfy all the criteria of the fourth Universal Definition of Myocardial Infarction
  6. The effects of INa current inhibition on endothelial function will be assessed at follow up as compared with control group. Endothelial function will be evaluated with the EndoPAT, measuring both the Endoscore and RHI
  7. The incidence of MACE, defined as composite of death, myocardial infarction, or target-vessel revascularization at short (42+/-7 days) term follow-up.
  8. Angina symptoms and quality of life will be assessed with SAQ7 and EuroQoL questionnaires and results compared between the two groups. Study Design This will be a prospective, multicenter, randomized (1:1 ratio), open-label, trial to evaluate the relative difference in terms of IMR and/or angioIMR measured both at baseline (after successful pPCI) and at follow-up (during staged PCI procedure).

Patients enrolled in the experimental group will receive ranolazine by oral administration, on top of regular therapy, starting with a dosage of 500mg bid and increased at 750mg bid starting from 7 days after pPCI up to 6 +/-2 weeks. Conversely, patients enrolled in the Control group will be managed, as per standard practice, with regular therapy only.

All comer patients undergoing successful pPCI for ST-segment elevation myocardial infarction (STEMI) will be screened for eligibility for study participation within six hours. STEMI will be defined by symptom onset within 24 hours and ST-segment elevation of ≥ 1 mm in 2 or more contiguous leads, true posterior MI, or new left bundle branch block. Patients who fulfil all inclusion criteria and do not meet any of the exclusion criteria will be eligible for trial inclusion soon after successful pPCI. Patients will be informed on the nature of the trial and of any potential harm or risk that the study may cause and will be assured of confidentiality. Patients will receive a copy of the signed and dated written informed consent form.

Being tested
Ranolazine
Keywords
STEMI, Coronary Microvascular Dysfunction, Ranolazine, Multivessel Coronary Artery Disease
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RanolazineDrug

    Patients enrolled in the experimental group will receive ranolazine by oral administration, on top of regular therapy, starting with a dosage of 500mg bid and increased at 750mg bid starting from 7 days after pPCI up to 6 +/-2 weeks.

Study groups in NCT07380919
Study groupRoleWhat they receive
Experimental GroupExperimentalPatients enrolled in the experimental group will receive ranolazine by oral administration, on top of regular therapy, starting with a dosage of 500mg bid and increased at 750mg bid starting from 7 days after pPCI up to 6 +/-2 weeks.
Receives: Drug: Ranolazine
Control GroupNo interventionPatients enrolled in the Control group will be managed, as per standard practice, with regular therapy only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preservation of the coronary microcirculation

    he relative difference in terms of IMR and/or angioIMR will be evaluated. IMR and/or angioIMR will be assessed both at the baseline (after successful coronary revascularization) and at the time of staged revascularization of the non-culprit stenosis (either at 5+/-2 days or within 6+/-2 weeks after pPCI).

    Measured: Up to 8 weeks

Secondary outcomes (9)

  1. Difference in terms of CMD prevalence between the two groups

    The prevalence of residual CMD downstream to the culprit vessel in the two group of patients. Residual CMD will be defined as the finding of an IMRculprit or angioIMRculprit value > 25

    Measured: Up to 8 weeks

  2. Infarct Size Extension

    The extent of the Infarct Size, as assessed by the CMR, in terms of grams (g) and percentage as compared with control group

    Measured: Up to 8 weeks

  3. CMD prevalence downstream to the non-culprit vessel before staged PCI

    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 angioIMRnon-culprit value > 25

    Measured: Up to 8 weeks

  4. CMD prevalence after staged PCI

    The incidence of peri-procedural CMD after staged PCI of the non-culprit stenoses, defined as a 20% increase of IMRnon-culprit or angioIMRnon-culprit values assessed before and after elective PCI of the non-culprit vessel.

    Measured: Up to 8 weeks

  5. Incidence of periprocedural MI eventually occurring after staged procedures

    The difference between the two groups of patients, in terms of incidence of periprocedural Myocardial Infarction (PMI), eventually occurring during the staged procedure. PMI require to satisfy all the criteria of the fourth Universal Definition of Myocardial Infarction

    Measured: Up to 8 weeks

  6. Incidence of MACE

    The incidence of MACE, defined as composite of death, myocardial infarction, or target-vessel revascularization at short (42+/-7 days) term follow-up.

    Measured: Up to 8 weeks

  7. Residual angina symptoms

    Angina symptoms will be assessed with The SAQ-7 (Seattle Angina Questionnaire-7) summary score which is a 0-100 validated measure of coronary artery disease (CAD) patient health status, averaging Physical Limitation, Angina Frequency, and Quality of Life domains. Higher scores (0-100) indicate better health status, less frequent angina, and improved quality of life and results compared between the two groups.

    Measured: Up to 8 weeks

  8. Patients' Quality of Life

    Quality of life will be assessed with the EQ5D5L including a vertical visual analogue scale (EQ VAS) that allows patients to self-rate their current, overall health-related quality of life from 0 ("worst imaginable health") to 100 ("best imaginable health").

    Measured: Up to 8 weeks

  9. Incidence of endothelial dysfunction

    The effects of INa current inhibition on endothelial function will be assessed at follow up as compared with control group. Endothelial function will be evaluated with the EndoPAT, measuring both the Endoscore and RHI

    Measured: Up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2026
  2. Study startFeb 2026 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This will be a prospective, multicenter, randomized (1:1 ratio), open-label, phase 2b trial to evaluate the relative difference in terms of IMR and/or angioIMR measured both at baseline (after successful pPCI) and at follow-up (during staged PCI procedure). Patients enrolled in the experimental group will receive ranolazine by oral administration, on top of regular therapy, starting with a dosage of 500mg bid and increased at 750mg bid starting from 7 days after pPCI up to 6 +/-2 weeks. Conversely, patients enrolled in the Control group will be managed, as per standard practice, with regular therapy only.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07380919
Sponsor's protocol ID
2025-520801-12-00
Other IDs
2025
Acronym
INaMICRON
Status last verified
Feb 2026
First submitted
15 Jan 2026
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: It will be shared upon request

Publications

  • Topal DG, Aleksov Ahtarovski K, Lonborg J, Hofsten D, Nepper-Christensen L, Kyhl K, Schoos M, Ghotbi AA, Goransson C, Bertelsen L, Holmvang L, Helqvist S, Pedersen F, Schnabel R, Kober L, Kelbaek H, Vejlstrup N, Engstrom T, Clemmensen P. Impact of age on reperfusion success and long-term prognosis in ST-segment elevation myocardial infarction - A cardiac magnetic resonance imaging study. Int J Cardiol Heart Vasc. 2021 Mar 2;33:100731. doi: 10.1016/j.ijcha.2021.100731. eCollection 2021 Apr.

    PubMed 33732867

  • Zeymer U, Ludman P, Danchin N, Kala P, Laroche C, Sadeghi M, Caporale R, Shaheen SM, Legutko J, Iakobsishvili Z, Alhabib KF, Motovska Z, Studencan M, Mimoso J, Becker D, Alexopoulos D, Kereseselidze Z, Stojkovic S, Zelveian P, Goda A, Mirrakhimov E, Bajraktari G, Al-Farhan H, Serpytis P, Raungaard B, Marandi T, Moore AM, Quinn M, Karjalainen PP, Tatu-Chitolu G, Gale CP, Maggioni AP, Weidinger F; ACVC EAPCI EORP ACS STEMI investigators group of the ESC. Reperfusion therapies and in-hospital outcomes for ST-elevation myocardial infarction in Europe: the ACVC-EAPCI EORP STEMI Registry of the European Society of Cardiology. Eur Heart J. 2021 Nov 21;42(44):4536-4549. doi: 10.1093/eurheartj/ehab342.

    PubMed 34389857

  • El Farissi M, Zimmermann FM, De Maria GL, van Royen N, van Leeuwen MAH, Carrick D, Carberry J, Wijnbergen IF, Konijnenberg LSF, Hoole SP, Marin F, Fineschi M, Pijls NHJ, Oldroyd KG, Banning AP, Berry C, Fearon WF. The Index of Microcirculatory Resistance After Primary PCI: A Pooled Analysis of Individual Patient Data. JACC Cardiovasc Interv. 2023 Oct 9;16(19):2383-2392. doi: 10.1016/j.jcin.2023.08.030.

    PubMed 37821183

  • Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.

    PubMed 30571511

  • Hamburg NM, Keyes MJ, Larson MG, Vasan RS, Schnabel R, Pryde MM, Mitchell GF, Sheffy J, Vita JA, Benjamin EJ. Cross-sectional relations of digital vascular function to cardiovascular risk factors in the Framingham Heart Study. Circulation. 2008 May 13;117(19):2467-74. doi: 10.1161/CIRCULATIONAHA.107.748574. Epub 2008 May 5.

    PubMed 18458169

  • Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41. doi: 10.1016/j.jacc.2004.08.062.

    PubMed 15582310

  • Mangiacapra F, Pellicano M, Di Serafino L, Bressi E, Peace AJ, Di Gioia G, Morisco C, Bartunek J, Wijns W, Bruyne B, Barbato E. Platelet reactivity and coronary microvascular impairment after percutaneous revascularization in stable patients receiving clopidogrel or prasugrel. Atherosclerosis. 2018 Nov;278:23-28. doi: 10.1016/j.atherosclerosis.2018.08.044. Epub 2018 Aug 30.

    PubMed 30236867

  • Mejia-Renteria H, Lee JM, Choi KH, Lee SH, Wang L, Kakuta T, Koo BK, Escaned J. Coronary microcirculation assessment using functional angiography: Development of a wire-free method applicable to conventional coronary angiograms. Catheter Cardiovasc Interv. 2021 Nov 15;98(6):1027-1037. doi: 10.1002/ccd.29863. Epub 2021 Jul 9.

    PubMed 34242489

  • Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Botker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14):e009603. doi: 10.1161/JAHA.118.009603.

    PubMed 29980523

  • De Bruyne B, Adjedj J, Xaplanteris P, Ferrara A, Mo Y, Penicka M, Flore V, Pellicano M, Toth G, Barbato E, Duncker DJ, Pijls NH. Saline-Induced Coronary Hyperemia: Mechanisms and Effects on Left Ventricular Function. Circ Cardiovasc Interv. 2017 Apr;10(4):e004719. doi: 10.1161/CIRCINTERVENTIONS.116.004719.

    PubMed 28400462

  • Gutierrez-Barrios A, Izaga-Torralba E, Rivero Crespo F, Gheorghe L, Canadas-Pruano D, Gomez-Lara J, Silva E, Noval-Morillas I, Zayas Rueda R, Calle-Perez G, Vazquez-Garcia R, Alfonso F. Continuous Thermodilution Method to Assess Coronary Flow Reserve. Am J Cardiol. 2021 Feb 15;141:31-37. doi: 10.1016/j.amjcard.2020.11.011. Epub 2020 Nov 19.

    PubMed 33220317

  • Gallinoro E, Candreva A, Colaiori I, Kodeboina M, Fournier S, Nelis O, Di Gioia G, Sonck J, van 't Veer M, Pijls NHJ, Collet C, De Bruyne B. Thermodilution-derived volumetric resting coronary blood flow measurement in humans. EuroIntervention. 2021 Oct 1;17(8):e672-e679. doi: 10.4244/EIJ-D-20-01092.

    PubMed 33528358

  • Keulards DCJ, Van 't Veer M, Zelis JM, El Farissi M, Zimmermann FM, de Vos A, Teeuwen K, Brueren GRG, Wijnbergen IF, Vlaar PJ, Tonino PAL, Pijls NHJ. Safety of absolute coronary flow and microvascular resistance measurements by thermodilution. EuroIntervention. 2021 Jun 25;17(3):229-232. doi: 10.4244/EIJ-D-20-00074. No abstract available.

    PubMed 32091402

  • Wijnbergen I, van 't Veer M, Lammers J, Ubachs J, Pijls NH. Absolute coronary blood flow measurement and microvascular resistance in ST-elevation myocardial infarction in the acute and subacute phase. Cardiovasc Revasc Med. 2016 Mar;17(2):81-7. doi: 10.1016/j.carrev.2015.12.013. Epub 2016 Jan 7.

    PubMed 26905054

  • Xaplanteris P, Fournier S, Keulards DCJ, Adjedj J, Ciccarelli G, Milkas A, Pellicano M, Van't Veer M, Barbato E, Pijls NHJ, De Bruyne B. Catheter-Based Measurements of Absolute Coronary Blood Flow and Microvascular Resistance: Feasibility, Safety, and Reproducibility in Humans. Circ Cardiovasc Interv. 2018 Mar;11(3):e006194. doi: 10.1161/CIRCINTERVENTIONS.117.006194.

    PubMed 29870386

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ranolazine in people with STEMI (ST Elevation MI), run by Federico II University at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Luigi Di Serafino, Professor (+390817462235, luigi.diserafino@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preservation of the coronary microcirculation (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07380919, which also lists 49 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in