Condition: STEMI (ST Elevation MI) · Sponsor: Federico II University
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 ass…
This description comes directly from the study's public registry record.
Luigi Di Serafino, Professor · +390817462235 · luigi.diserafino@unina.it
Always discuss trial participation with your own doctor first.
| Department of Medical and Surgical Sciences and "Renato Dulbecco" University Hospital, "Magna Graecia" University | Catanzaro, Italy, Italy | Recruiting |
| Department of Cardiology, Santa Maria Goretti Hospital, Latina, Italy | Latina, Italy, Italy | Not Yet Recruiting |
| Federico II University Hospital - Division of Cardiology | Naples, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07380919