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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)
EU CTIS ID: 2025-520801-12-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)..
You likely can't join if
- Hemodynamically unstable patients
- 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.
- 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
See the full eligibility criteria
- 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)..
- Hemodynamically unstable patients
- 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.
- 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.