China-Administration of Nicorandil Group（CHANGE）

Phase 4

Completed

• Conditions: Percutaneous Coronary Intervention; Myocardial Infarction; Nicorandil
• Interventions: Other: Placebo; Drug: Nicorandil

• Registration Number: NCT03445728
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-20
• Study Start: 2018-02-24
• Study First Posted: 2018-02-26
• Primary Completion: 2020-07-31
• Study Completion: 2021-10-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo	Patients were randomly assigned to two groups before emergent coronary angiography, those who received placebo before and after reperfusion with PCI.
Treatment arm	Nicorandil	Patients were randomly assigned to two groups before emergent coronary angiography: those who received intravenous (iv.) nicorandil before and after (ivgtt.) reperfusion with PCI (nicorandil group);

Primary Outcome Measures

Name	Time	Method
Infarct size as measured by cardiac MRI	7 days after primary PCI	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.

Secondary Outcome Measures

Name	Time	Method
ST-segment fall rate of electrocardiogram (ECG)	2 hours after the procedure	Complete ST-segment resolution at 2 h after PCI
Edema size (LV area %) measured by cardiac MRI	7 days after the procedure	Edema size
Corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC)	5 minutes after stent implantation during PCI	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
Incidence of slow flow/no-reflow	5 minutes after stent implantation during PCI	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
CIN	48-72 hours after primary PCI	contrast induced nephropathy
Infarct size as measured by cardiac MRI	6 months after PCI	The myocardial infarct size was derived from the program's automatic analysis of delayed enhancement images.
Serum creatinine kinase (CK-MB) level	Baseline, 6, 12, 18, 24 hours after the PCI	Change of serum creatinine kinase
Microvascular obstructionmeasured by cardiac MRI	7 days after the procedure	Microvascular obstructionmeasured
MACE	up to 12 months	all-cause death, cardiovascular death, , Rehospitalization for heart failure, Unplanned PCI After PPCI
LV Ejection fraction (%) as measured by cardiac MRI	6 months after the procedure	LV Ejection fraction in late phase

Trial Locations

Locations (1)

CHINA; 🇨🇳 Beijing, China