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Completed

NCT Number: NCT03445728

China-Administration of Nicorandil Group(CHANGE)

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHINA

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • SBP<80mmHg;
  • LM stenosis
  • Aortic dissection;
  • AMI (<6 month)
  • PCI或CABG (<6 month)
  • Already under the treatment of Nicorandil;
  • Contraindicated or intolerable to Nicorandil
  • severe adverse effects to CMR or MRI;
  • Currently (or within one month) participating in another new drug trial.;
  • Pregnant or lactation period;
  • 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;

Treatment and study plan

nicorandil

Drug

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

Placebo

Other

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

Primary outcomes

  1. Infarct size as measured by cardiac MRI

    Time frame: 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 outcomes

  1. Infarct size as measured by cardiac MRI

    Time frame: 6 months after PCI

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

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

    Time frame: 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

  3. Incidence of slow flow/no-reflow

    Time frame: 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

  4. ST-segment fall rate of electrocardiogram (ECG)

    Time frame: 2 hours after the procedure

    Complete ST-segment resolution at 2 h after PCI

  5. Serum creatinine kinase (CK-MB) level

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

    Change of serum creatinine kinase

  6. Edema size (LV area %) measured by cardiac MRI

    Time frame: 7 days after the procedure

    Edema size

  7. Microvascular obstructionmeasured by cardiac MRI

    Time frame: 7 days after the procedure

    Microvascular obstructionmeasured

  8. LV Ejection fraction (%) as measured by cardiac MRI

    Time frame: 7 days after the procedure

    LV Ejection fraction in early phase

  9. LV Ejection fraction (%) as measured by cardiac MRI

    Time frame: 6 months after the procedure

    LV Ejection fraction in late phase

  10. MACE

    Time frame: up to 12 months

    all-cause death, cardiovascular death, , Rehospitalization for heart failure, Unplanned PCI After PPCI

  11. CIN

    Time frame: 48-72 hours after primary PCI

    contrast induced nephropathy

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Beijing Chao Yang Hospital
  • First People's Hospital of Yulin
  • Guizhou Provincial People's Hospital
  • Hainan General Hospital
  • Second Affiliated Hospital of Nanchang University
  • The Second Hospital of Hebei Medical University
  • Wuhan Asia Heart Hospital
  • Zunyi Medical College

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 26, 2018
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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