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New treatment option for STEMI (ST Elevation MI)
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
ClinicalTrials.gov ID: NCT07380919
What this study is testing
What is Ranolazine?
Ranolazine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for stemi (st elevation mi).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
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
You likely can't join if
- 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...
- Known hypersensitivity to the active principle (Ranolazine) or any of the excipients
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 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Catanzaro, Italy, Italy
- Latina, Italy, Italy
- Naples, Italy
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 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Catanzaro, Italy, Italy; Latina, Italy, Italy; Naples, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.