Clinical trial NCT03445728: China-Administration of Nicorandil Group（CHANGE）
Official title: Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Percutaneous Coronary Intervention
Nicorandil
Keywords: Cardiac magnetic resonance; Infarct Size
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: First People's Hospital of Yulin
name: Beijing Chao Yang Hospital
name: Wuhan Asia Heart Hospital
name: Hainan Hospital of PLA General Hospital
name: Zunyi Medical College
name: Guizhou Provincial People's Hospital
name: Second Affiliated Hospital of Nanchang University
name: The Second Hospital of Hebei Medical University
First posted: 2018-02-26
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Infarct size as measured by cardiac MRI
timeFrame: 7 days after primary PCI
Secondary outcomes:
measure: Infarct size as measured by cardiac MRI
timeFrame: 6 months after PCI
measure: Corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC)
timeFrame: 5 minutes after stent implantation during PCI
measure: Incidence of slow flow/no-reflow
timeFrame: 5 minutes after stent implantation during PCI
measure: ST-segment fall rate of electrocardiogram (ECG)
timeFrame: 2 hours after the procedure
measure: Serum creatinine kinase (CK-MB) level
timeFrame: Baseline, 6, 12, 18, 24 hours after the PCI
measure: Edema size (LV area %) measured by cardiac MRI
timeFrame: 7 days after the procedure
measure: Microvascular obstructionmeasured by cardiac MRI
timeFrame: 7 days after the procedure
measure: LV Ejection fraction (%) as measured by cardiac MRI
timeFrame: 7 days after the procedure
measure: LV Ejection fraction (%) as measured by cardiac MRI
timeFrame: 6 months after the procedure
measure: MACE
timeFrame: up to 12 months
measure: CIN
timeFrame: 48-72 hours after primary PCI
Other outcomes:
Locations:
city: Beijing
country: China
facility: CHINA
Study officials:
affiliation: Chinese PLA General Hospital
name: Yundai Chen
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Qian G, Zhang Y, Dong W, Jiang ZC, Li T, Cheng LQ, Zou YT, Jiang XS, Zhou H, A X, Li P, Chen ML, Su X, Tian JW, Shi B, Li ZZ, Wu YQ, Li YJ, Chen YD. Effects of Nicorandil Administration on Infarct Size in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: The CHANGE Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e026232. doi: 10.1161/JAHA.122.026232. Epub 2022 Sep 8.