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Myocardial InfarctionPhase 4NCT03445728

China-Administration of Nicorandil Group（CHANGE）

A Phase 4 study testing Nicorandil in people with Myocardial Infarction and Percutaneous Coronary Intervention, run by Chinese PLA General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Nicorandil
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
238 participants
Where
1 siteChina
Study dates
24 Feb 2018to 1 Oct 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • SBP<80mmHg；
  • LM stenosis
  • Aortic dissection；
  • AMI (<6 month)
  • PCI或CABG (<6 month)
  • Already under the treatment of Nicorandil；
Show all 11Show fewer
  • 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;

Trial locations and contacts

1 site in 1 country.

China1 site

  • CHINA

    Beijing

Other trials in China

About this study

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

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

Read the 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.

Being tested
Nicorandil, Placebo
Keywords
Cardiac magnetic resonance; Infarct Size
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

Study groups in NCT03445728
Study groupRoleWhat they receive
Treatment armExperimentalPatients 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);
Receives: Drug: Nicorandil
Placebo armPlacebo comparatorPatients were randomly assigned to two groups before emergent coronary angiography, those who received placebo before and after reperfusion with PCI.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7 days after primary PCI

Secondary outcomes (11)

  1. Infarct size as measured by cardiac MRI

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

    Measured: 6 months after PCI

  2. 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

    Measured: 5 minutes after stent implantation during PCI

  3. 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

    Measured: 5 minutes after stent implantation during PCI

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

    Complete ST-segment resolution at 2 h after PCI

    Measured: 2 hours after the procedure

  5. Serum creatinine kinase (CK-MB) level

    Change of serum creatinine kinase

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

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

    Edema size

    Measured: 7 days after the procedure

  7. Microvascular obstructionmeasured by cardiac MRI

    Microvascular obstructionmeasured

    Measured: 7 days after the procedure

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

    LV Ejection fraction in early phase

    Measured: 7 days after the procedure

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

    LV Ejection fraction in late phase

    Measured: 6 months after the procedure

  10. MACE

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

    Measured: up to 12 months

  11. CIN

    contrast induced nephropathy

    Measured: 48-72 hours after primary PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2018
  2. Study start24 Feb 2018
  3. Primary completion31 Jul 2020
  4. Study completion1 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
238 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03445728
Sponsor's protocol ID
CHANGE 001
Status last verified
Nov 2021
First submitted
2 Feb 2018
Last updated
24 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 16116055

  • 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.

    PubMed 10080465

  • 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.

    PubMed 17964349

  • 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.

    PubMed 28279370

  • 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.

    PubMed 17478142

  • 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.

    PubMed 11965271

  • 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.

    PubMed 11693742

  • 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.

    PubMed 26012474

  • 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.

    PubMed 36073634

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nicorandil in people with Myocardial Infarction and Percutaneous Coronary Intervention, run by Chinese PLA General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infarct size as measured by cardiac MRI (time frame: 7 days after primary PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03445728, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.

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