Intravenous Nicorandil During Primary Percutaneous Coronary intervention in Patients with ST-Elevation Myocardial Infarction: Rationale and Design of the CLinical Efficacy and sAfety of intravenous Nicorandil (CLEAN) trial.

Abstract BACKGROUND The efficacy and safety of intravenous infusion of nicorandil during primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI) remain uncertain. OBJECTIVES The primary objective of the CLinical Efficacy and sAfety of intravenous Nicorandil (CLEAN) trial is to evaluate the long-term efficacy and safety of intravenous administration of nicorandil as adjuncts to reperfusion therapy in patients with STEMI undergoing primary PCI. DESIGN The CLEAN trial is a multicenter, randomized, double-blind, placebo-controlled trial that will enroll 1,500 patients from 40 centers across China. Patients were randomly (1:1) assigned to receive intravenous nicorandil (6 mg as a bolus before reperfusion, followed by 48 hours of continuous infusion at a dose of 6 mg/h after coronary intervention) or the same dose of placebo according to randomization. The primary efficacy outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, target vessel revascularization, and unplanned hospitalization for heart failure within 12 months. The secondary efficacy outcomes included the individual components of the combined efficacy endpoint, incidence of slow coronary flow after PCI, and incidence of complete ST-segment resolution at 2 hours after PCI. The safety outcomes included the incidence of hypotension after drug infusion and other adverse events during medication. SUMMARY CLEAN will determine whether the addition of intravenous nicorandil as adjuncts to reperfusion therapy reduces the major adverse cardiovascular events in STEMI patients undergoing primary PCI. TRIAL REGISTRATION ClinicalTrials.gov, NCT04665648