Prophylactically injection of Nicorandil to reduce no-reflow phenomenon during PCI in acute STEMI patients: Protocol of a double-blinded, randomized, placebo-controlled trial.

Abstract

INTRODUCTION:

An acute ST-elevation myocardial infarction (STEMI) is a very serious type of heart attack and a profoundly life-threatening medical emergency, and percutaneous coronary intervention (PCI) is the preferred strategy. However, in patients undergoing primary PCI, 30% to 40% may suffer the no-reflow phenomenon (NRP), and it could expand the myocardial infarction area and accompanied with high rehospitalization rate and fatality rate. In this study, we try to conduct a double blinded, randomized, placebo-controlled trial to observe whether the prophylactically intracoronary administration of Nicorandil could reduce the occurrence of NRP in STEMI patients undergoing PCI.

METHODS:

Simple randomization in a 1:1 ratio will be made in blocks of variable size according to a random numbers generated by Excel 2010 to divide the patients to treatment group (Nicorandil) and control group (Saline). The outcomes are the occurrence of NRP, levels of interleukin-6 and HS-CRP, cTnT, and CK-MB before, and every 4 hours following PCI, and major adverse cardiovascular events at day 30. SPSS 23.0 (IBM, Chicago, IL) will be used, and P-value < .05 will be considered statistically significant.

CONCLUSIONS:

The findings will determine the efficacy of prophylactically intracoronary administration of Nicorandil to reduce the occurrence of NRP during PCI in acute STEMI patients.

TRIAL REGISTRATION:

OSF Registration number: DOI 10.17605/OSF.IO/QPF3V.

• Authors: Su An, Huopeng Huang, Huaying Wang, Yunlu Jiang
• Journal: Medicine (Medicine (Baltimore)) Vol. 100 Issue 15 Pg. e25500 (Apr 16 2021) ISSN: 1536-5964 [Electronic] United States
• PMID: 33847663 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

Chemical References

• Vasodilator Agents
• Nicorandil

Topics

• Acute Disease
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Double-Blind Method
• Female
• Humans
• Injections
• Male
• Middle Aged
• Nicorandil (administration & dosage)
• No-Reflow Phenomenon (etiology, prevention & control)
• Percutaneous Coronary Intervention (adverse effects)
• Randomized Controlled Trials as Topic
• ST Elevation Myocardial Infarction (surgery)
• Treatment Outcome
• Vasodilator Agents (administration & dosage)
• Young Adult