China-Administration of Nicorandil Group（CHANGE）

Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

We compared the infarct size in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) treated by nicorandil before and after the reperfusion with those standard therapy treated by PCI

The aim of this study was to evaluate the efficacy and safety of nicorandil in improving myocardial infarct size in patients with acute myocardial infarction through a multi-center, prospective, randomized, double-blind and parallel-controlled clinical study, providing evidence-based support for the optimization of PCI treatment strategies. The primary objective of the study was to compare whether the effect of nicorandil in combination with PCI was significantly better at reducing the myocardial infarct size than that of PCI alone in AMI patients.

Inclusion Criteria:

1. Acute ST-T elevation MI patients (<12h)
2. undergoing emergency PCI；
3. Subject has read and signed a written, informed consent form.

Exclusion Criteria:

1. SBP<80mmHg；
2. LM stenosis
3. Aortic dissection；
4. AMI (<6 month)
5. PCI或CABG (<6 month)
6. Already under the treatment of Nicorandil；
7. Contraindicated or intolerable to Nicorandil
8. severe adverse effects to CMR or MRI；
9. Currently (or within one month) participating in another new drug trial.；
10. Pregnant or lactation period；
11. Severe somatic disease preventing the participant from completing the trial, or based on the discretion of the investigators, the patient is incapable of participating; Individuals with abnormal laboratory test results and/or clinical manifestations rendering them unsuitable to participate as judged by the investigators;