China-Administration of Nicorandil Group（CHANGE）

Chinese PLA General Hospital238 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

238

Conditions

Myocardial Infarction Percutaneous Coronary Intervention Nicorandil

Interventions

NicorandilDRUG

After randomization, receive primary PCI and standard therapy, 12mg Nicorandil iv. just before ballooning or stenting, then keep Nicorandil 6mg/h ivgtt. up to 24h

PlaceboOTHER

After randomization, receive primary PCI and standard therapy, just like the intervension group also iv. just before ballooning or stenting, then keep ivgtt. up to 24h

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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;

Locations (1)

CHINA

Beijing, China

Outcomes

Primary Outcomes

Infarct size as measured by cardiac MRI

The myocardial infarct size was derived by measuring the area of delay-enhanced image-enhanced MRI, which was judged and analyzed by two experienced MRI cardiac diagnosticians.

Time frame: 7 days after primary PCI

Secondary Outcomes

Infarct size as measured by cardiac MRI

The myocardial infarct size was derived from the program's automatic analysis of delayed enhancement images.

Time frame: 6 months after PCI

Corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC)

the starting point is the number of frames in which the contrast agent completely or nearly completely filled the beginning of the coronary artery and touched both sides of the coronary vessel wall, and the end point is the number of frames in which the contrast agent entered the distal branch vessel and developed a specific anatomical marker

Time frame: 5 minutes after stent implantation during PCI

Incidence of slow flow/no-reflow

When scanning at a rate of 15 frames per second, cTFC \> 27 frames per second was used as the criterion for the diagnosis of slow blood flow after primary PCI

Time frame: 5 minutes after stent implantation during PCI

ST-segment fall rate of electrocardiogram (ECG)

Complete ST-segment resolution at 2 h after PCI

Time frame: 2 hours after the procedure

Serum creatinine kinase (CK-MB) level

Change of serum creatinine kinase

Time frame: Baseline, 6, 12, 18, 24 hours after the PCI

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.