Back to resultsChina-Administration of Nicorandil Group（CHANGE）
Primary Purpose
Myocardial Infarction, Percutaneous Coronary Intervention, Nicorandil
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nicorandil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Cardiac magnetic resonance; Infarct Size
Eligibility Criteria
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;
Sites / Locations
- CHINA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment arm
Placebo arm
Arm Description
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);
Patients were randomly assigned to two groups before emergent coronary angiography, those who received placebo before and after reperfusion with PCI.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Infarct size as measured by cardiac MRI
The myocardial infarct size was derived from the program's automatic analysis of delayed enhancement images.
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
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
ST-segment fall rate of electrocardiogram (ECG)
Complete ST-segment resolution at 2 h after PCI
Serum creatinine kinase (CK-MB) level
Change of serum creatinine kinase
Edema size (LV area %) measured by cardiac MRI
Edema size
Microvascular obstructionmeasured by cardiac MRI
Microvascular obstructionmeasured
LV Ejection fraction (%) as measured by cardiac MRI
LV Ejection fraction in early phase
LV Ejection fraction (%) as measured by cardiac MRI
LV Ejection fraction in late phase
MACE
all-cause death, cardiovascular death, , Rehospitalization for heart failure, Unplanned PCI After PPCI
CIN
contrast induced nephropathy
Full Information
NCT ID
NCT03445728
First Posted
February 2, 2018
Last Updated
November 18, 2021
Sponsor
Chinese PLA General Hospital
Collaborators
First People's Hospital of Yulin, Beijing Chao Yang Hospital, Wuhan Asia Heart Hospital, Hainan Hospital of PLA General Hospital, Zunyi Medical College, Guizhou Provincial People's Hospital, Second Affiliated Hospital of Nanchang University, The Second Hospital of Hebei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03445728
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 24, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
First People's Hospital of Yulin, Beijing Chao Yang Hospital, Wuhan Asia Heart Hospital, Hainan Hospital of PLA General Hospital, Zunyi Medical College, Guizhou Provincial People's Hospital, Second Affiliated Hospital of Nanchang University, The Second Hospital of Hebei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Percutaneous Coronary Intervention, Nicorandil
Keywords
Cardiac magnetic resonance; Infarct Size
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
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);
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Patients were randomly assigned to two groups before emergent coronary angiography, those who received placebo before and after reperfusion with PCI.
Intervention Type
Drug
Intervention Name(s)
Nicorandil
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Infarct size as measured by cardiac MRI
Description
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 Outcome Measure Information:
Title
Infarct size as measured by cardiac MRI
Description
The myocardial infarct size was derived from the program's automatic analysis of delayed enhancement images.
Time Frame
6 months after PCI
Title
Corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC)
Description
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
Title
Incidence of slow flow/no-reflow
Description
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
Title
ST-segment fall rate of electrocardiogram (ECG)
Description
Complete ST-segment resolution at 2 h after PCI
Time Frame
2 hours after the procedure
Title
Serum creatinine kinase (CK-MB) level
Description
Change of serum creatinine kinase
Time Frame
Baseline, 6, 12, 18, 24 hours after the PCI
Title
Edema size (LV area %) measured by cardiac MRI
Description
Edema size
Time Frame
7 days after the procedure
Title
Microvascular obstructionmeasured by cardiac MRI
Description
Microvascular obstructionmeasured
Time Frame
7 days after the procedure
Title
LV Ejection fraction (%) as measured by cardiac MRI
Description
LV Ejection fraction in early phase
Time Frame
7 days after the procedure
Title
LV Ejection fraction (%) as measured by cardiac MRI
Description
LV Ejection fraction in late phase
Time Frame
6 months after the procedure
Title
MACE
Description
all-cause death, cardiovascular death, , Rehospitalization for heart failure, Unplanned PCI After PPCI
Time Frame
up to 12 months
Title
CIN
Description
contrast induced nephropathy
Time Frame
48-72 hours after primary PCI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yundai Chen
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHINA
City
Beijing
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
16116055
Citation
Ishii H, Ichimiya S, Kanashiro M, Amano T, Imai K, Murohara T, Matsubara T. Impact of a single intravenous administration of nicorandil before reperfusion in patients with ST-segment-elevation myocardial infarction. Circulation. 2005 Aug 30;112(9):1284-8. doi: 10.1161/CIRCULATIONAHA.104.530329. Epub 2005 Aug 22.
Results Reference
result
PubMed Identifier
10080465
Citation
Ito H, Taniyama Y, Iwakura K, Nishikawa N, Masuyama T, Kuzuya T, Hori M, Higashino Y, Fujii K, Minamino T. Intravenous nicorandil can preserve microvascular integrity and myocardial viability in patients with reperfused anterior wall myocardial infarction. J Am Coll Cardiol. 1999 Mar;33(3):654-60. doi: 10.1016/s0735-1097(98)00604-4.
Results Reference
result
PubMed Identifier
17964349
Citation
Kitakaze M, Asakura M, Kim J, Shintani Y, Asanuma H, Hamasaki T, Seguchi O, Myoishi M, Minamino T, Ohara T, Nagai Y, Nanto S, Watanabe K, Fukuzawa S, Hirayama A, Nakamura N, Kimura K, Fujii K, Ishihara M, Saito Y, Tomoike H, Kitamura S; J-WIND investigators. Human atrial natriuretic peptide and nicorandil as adjuncts to reperfusion treatment for acute myocardial infarction (J-WIND): two randomised trials. Lancet. 2007 Oct 27;370(9597):1483-93. doi: 10.1016/S0140-6736(07)61634-1. Erratum In: Lancet. 2008 Dec 22;370(9605):2102.
Results Reference
result
PubMed Identifier
28279370
Citation
Bulluck H, Hammond-Haley M, Weinmann S, Martinez-Macias R, Hausenloy DJ. Myocardial Infarct Size by CMR in Clinical Cardioprotection Studies: Insights From Randomized Controlled Trials. JACC Cardiovasc Imaging. 2017 Mar;10(3):230-240. doi: 10.1016/j.jcmg.2017.01.008.
Results Reference
result
PubMed Identifier
17478142
Citation
Ishii H, Ichimiya S, Kanashiro M, Amano T, Ogawa Y, Mitsuhashi H, Sakai S, Uetani T, Murakami R, Naruse K, Murohara T, Matsubara T. Effect of intravenous nicorandil and preexisting angina pectoris on short- and long-term outcomes in patients with a first ST-segment elevation acute myocardial infarction. Am J Cardiol. 2007 May 1;99(9):1203-7. doi: 10.1016/j.amjcard.2006.12.034. Epub 2007 Mar 16.
Results Reference
result
PubMed Identifier
11965271
Citation
IONA Study Group. Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in Angina (IONA) randomised trial. Lancet. 2002 Apr 13;359(9314):1269-75. doi: 10.1016/S0140-6736(02)08265-X. Erratum In: Lancet 2002 Sep 7;360(9335):806.
Results Reference
result
PubMed Identifier
11693742
Citation
Okamura A, Rakugi H, Ohishi M, Yanagitani Y, Shimizu M, Nishii T, Taniyama Y, Asai T, Takiuchi S, Moriguchi K, Ohkuro M, Komai N, Yamada K, Inamoto N, Otsuka A, Higaki J, Ogihara T. Additive effects of nicorandil on coronary blood flow during continuous administration of nitroglycerin. J Am Coll Cardiol. 2001 Mar 1;37(3):719-25. doi: 10.1016/s0735-1097(00)01171-2.
Results Reference
result
PubMed Identifier
26012474
Citation
Kostic J, Djordjevic-Dikic A, Dobric M, Milasinovic D, Nedeljkovic M, Stojkovic S, Stepanovic J, Tesic M, Trifunovic Z, Zamaklar-Tifunovic D, Radosavljevic-Radovanovic M, Ostojic M, Beleslin B. The effects of nicorandil on microvascular function in patients with ST segment elevation myocardial infarction undergoing primary PCI. Cardiovasc Ultrasound. 2015 May 27;13:26. doi: 10.1186/s12947-015-0020-9.
Results Reference
result
PubMed Identifier
36073634
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.
Results Reference
derived
Learn more about this trial
China-Administration of Nicorandil Group（CHANGE）
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