China-Administration of Nicorandil Group（CHANGE）

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445728
• Other study ID #: CHANGE 001
• Status: Completed
• Phase: Phase 4
• Start date: February 24, 2018
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2021
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: October 1, 2021
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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?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;

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Nicorandil
• Percutaneous Coronary Intervention

Intervention

Drug:
• Nicorandil
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

Other:
• Placebo
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

Locations

Country	Name	City	State
China	CHINA	Beijing

Sponsors (9)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Beijing Chao Yang Hospital, First People's Hospital of Yulin, Guizhou Provincial People's Hospital, Hainan Hospital of PLA General Hospital, Second Affiliated Hospital of Nanchang University, The Second Hospital of Hebei Medical University, Wuhan Asia Heart Hospital, Zunyi Medical College

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View 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. Erratum in: Lancet 2002 Sep 7;360(9335):806. — View 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. — View 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 — View 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 — View 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 investigato — View 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 patien — View 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 a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days after primary PCI
Secondary	Infarct size as measured by cardiac MRI	The myocardial infarct size was derived from the program's automatic analysis of delayed enhancement images.	6 months after PCI
Secondary	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	5 minutes after stent implantation during PCI
Secondary	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	5 minutes after stent implantation during PCI
Secondary	ST-segment fall rate of electrocardiogram (ECG)	Complete ST-segment resolution at 2 h after PCI	2 hours after the procedure
Secondary	Serum creatinine kinase (CK-MB) level	Change of serum creatinine kinase	Baseline, 6, 12, 18, 24 hours after the PCI
Secondary	Edema size (LV area %) measured by cardiac MRI	Edema size	7 days after the procedure
Secondary	Microvascular obstructionmeasured by cardiac MRI	Microvascular obstructionmeasured	7 days after the procedure
Secondary	LV Ejection fraction (%) as measured by cardiac MRI	LV Ejection fraction in early phase	7 days after the procedure
Secondary	LV Ejection fraction (%) as measured by cardiac MRI	LV Ejection fraction in late phase	6 months after the procedure
Secondary	MACE	all-cause death, cardiovascular death, , Rehospitalization for heart failure, Unplanned PCI After PPCI	up to 12 months
Secondary	CIN	contrast induced nephropathy	48-72 hours after primary PCI