NCT03445728

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

February 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

2.4 years

First QC Date

February 2, 2018

Last Update Submit

November 18, 2021

Conditions

Myocardial InfarctionPercutaneous Coronary InterventionNicorandil

Keywords

Cardiac magnetic resonance; Infarct Size

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Infarct size as measured by cardiac MRI

    6 months after PCI

  • Corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC)

    5 minutes after stent implantation during PCI

  • Incidence of slow flow/no-reflow

    5 minutes after stent implantation during PCI

  • ST-segment fall rate of electrocardiogram (ECG)

    2 hours after the procedure

  • Serum creatinine kinase (CK-MB) level

    Baseline, 6, 12, 18, 24 hours after the PCI

  • +6 more secondary outcomes

Study Arms (2)

Treatment arm

EXPERIMENTAL

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);

Drug: Nicorandil

Placebo arm

PLACEBO COMPARATOR

Patients were randomly assigned to two groups before emergent coronary angiography, those who received placebo before and after reperfusion with PCI.

Other: Placebo

Interventions

NicorandilDRUG

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

Treatment arm
PlaceboOTHER

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

Placebo arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHINA

Beijing, China

Location

Related Publications (9)

  • 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.

    PMID: 16116055RESULT

  • 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.

    PMID: 10080465RESULT

  • 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.

    PMID: 17964349RESULT

  • 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.

    PMID: 28279370RESULT

  • 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.

    PMID: 17478142RESULT

  • 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.

    PMID: 11965271RESULT

  • 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.

    PMID: 11693742RESULT

  • 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.

    PMID: 26012474RESULT

  • 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.

    PMID: 36073634DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Nicorandil

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

NitratesOrganic ChemicalsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Yundai Chen

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 26, 2018

Study Start

February 24, 2018

Primary Completion

July 31, 2020

Study Completion

October 1, 2021

Last Updated

November 24, 2021

Record last verified: 2021-11

Locations

CN(1)