No-Reflow PhenomenonPhase 4NCT05427786

A Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT reductioN Of decREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease

A Phase 4 study testing Nicorandil in people with No-Reflow Phenomenon and Coronary Artery Disease, run by Korea University Anam Hospital at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The aim of this study was to determine the effect of intra-coronary administration of nicorandil on the prevention of lowering of coronary blood flow for high-risk plaque lesions defined as the high value of lipid core burden index in patients with coronary artery disease who require stent treatment. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: No-Reflow Phenomenon, Coronary Artery Disease, Percutaneous Coronary Intervention
What is being tested?: Nicorandil
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 458 participants
Where: 1 siteSouth Korea
Study dates: 14 Dec 2022to May 2028
Phase: Phase 4
Are there results?: Not yet: the study is under way

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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Over 19 years old
Patients who agree to the study plan and clinical follow-up plan, voluntarily decide to participate in this study, and consent in writing to the consent to use information
Patients who underwent NIRS-IVUS guided coronary stent surgery for coronary artery disease
maxLCBI4mm ≥354 in the culprit lesion measured by NIRS-IVUS

Who cannot join

Patients with TIMI ≤ 2 before coronary intervention
Subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel And contrast agents (however, even a subject who is hypersensitive to contrast agents can register if they can be controlled by steroids and pheniramine, except for known anaphylaxis.)
Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
Subjects who plan to have surgery to stop antiplatelet drugs within 6 months from registration
Those whose surviving life is expected to be less than 1 year
Subjects who visited the hospital due to cardiogenic shock and are predicted to have low survival probability based on medical judgment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site, 1 recruiting

Korea University Anam Hospital
Seoul
Jung Joon Cha, MD, PhD, 8229205445, joonletter@hanmail.net
Recruiting

Other trials in South Korea

About this study

Official title: A Randomized, Open Label, Parallel-group Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT reductioN Of decREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease

Conditions: No-Reflow Phenomenon, Coronary Artery Disease, Percutaneous Coronary Intervention
Being tested: Nicorandil
Keywords: Nicorandil, No-reflow phenomenon, lipid core burden index, near-infrared spectroscopy
Medical subject headings: No-Reflow Phenomenon, Coronary Artery Disease

What participants receive

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

NicorandilDrug
Administer 8cc or more of the prescribed drug according to randomization into the coronary artery before starting balloon therapy. The stent treatment method follows the standard treatment method.

Study groups in NCT05427786
Study group	Role	What they receive
Pre-PCI IC Nicorandil	Experimental	If the lipid core burden index at the main lesion site on vascular ultrasound exceeds 353, randomization was performed. Nicorandil group will be administrated 8cc or more of the prescribed drug (Nicroandil) according to randomization into the coronary artery before starting balloon therapy. Receives: Drug: Nicorandil
Standard PCI	No intervention	If the lipid core burden index at the main lesion site on vascular ultrasound exceeds 353, randomization was performed. Standard PCI group will be performed coronary intervention including starting balloon therapy without pre-administrated nicorandil.

What is being measured

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

Occurrence of decreased TIMI flow
occurrence of decreased TIMI flow (0,1,2) during the index procedure
Grade 0-No perfusion
Grade 1-Penetration without perfusion
Grade 2-Partial perfusion but not reach complete perfusion
Grade 3-Complete perfusion;; antegrade flow into the bed distal to the obstruction occurs as promptly as antegrade flow into the bed proximal to the obstruction, and clearance of contrast material from the involved bed is as rapid as clearance from an uninvolved bed in the same vessel or the opposite artery.
Measured: during procedure

Secondary outcomes (9)

Change of cardiac biomarker level after intervention
level change of CPK
Measured: 1 month
Change of cardiac biomarker level after intervention
level change of CK-MB
Measured: 1 month
Change of cardiac biomarker level after intervention
level change of Troponin T
Measured: 1 month
Change of cardiac biomarker level after intervention
level change of Troponin I
Measured: 1 month
patient-oriented composite end point
composite of all cause mortality, any myocardial infarction, and any revascularization
Measured: 1 year
Percentage of All cause mortality
Measured: 1 year
Percentage of cardiac death
Measured: 1 year
Percentage of myocardial infarction
Measured: 1 year
Percentage of revascularization
Measured: 1 year

Timeline

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

14 Dec 2022May 2028

First posted22 Jun 2022
Study start14 Dec 2022
Primary completionMay 2027 (estimated)
Study completionMay 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for No-Reflow PhenomenonStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 458 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05427786
Sponsor's protocol ID: PREVENT NO-REFLOW
Status last verified: Sep 2026
First submitted: 14 Jun 2022
Last updated: 8 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The data generated in this study is available from the corresponding author(s) upon reasonable request.

Publications

GUSTO Angiographic Investigators. The effects of tissue plasminogen activator, streptokinase, or both on coronary-artery patency, ventricular function, and survival after acute myocardial infarction. N Engl J Med. 1993 Nov 25;329(22):1615-22. doi: 10.1056/NEJM199311253292204.
PubMed 8232430
Morishima I, Sone T, Okumura K, Tsuboi H, Kondo J, Mukawa H, Matsui H, Toki Y, Ito T, Hayakawa T. Angiographic no-reflow phenomenon as a predictor of adverse long-term outcome in patients treated with percutaneous transluminal coronary angioplasty for first acute myocardial infarction. J Am Coll Cardiol. 2000 Oct;36(4):1202-9. doi: 10.1016/s0735-1097(00)00865-2.
PubMed 11028471
Piana RN, Paik GY, Moscucci M, Cohen DJ, Gibson CM, Kugelmass AD, Carrozza JP Jr, Kuntz RE, Baim DS. Incidence and treatment of 'no-reflow' after percutaneous coronary intervention. Circulation. 1994 Jun;89(6):2514-8. doi: 10.1161/01.cir.89.6.2514.
PubMed 8205658
Harrison RW, Aggarwal A, Ou FS, Klein LW, Rumsfeld JS, Roe MT, Wang TY; American College of Cardiology National Cardiovascular Data Registry. Incidence and outcomes of no-reflow phenomenon during percutaneous coronary intervention among patients with acute myocardial infarction. Am J Cardiol. 2013 Jan 15;111(2):178-84. doi: 10.1016/j.amjcard.2012.09.015. Epub 2012 Oct 27.
PubMed 23111142
Endo M, Hibi K, Shimizu T, Komura N, Kusama I, Otsuka F, Mitsuhashi T, Iwahashi N, Okuda J, Tsukahara K, Kosuge M, Ebina T, Umemura S, Kimura K. Impact of ultrasound attenuation and plaque rupture as detected by intravascular ultrasound on the incidence of no-reflow phenomenon after percutaneous coronary intervention in ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2010 May;3(5):540-9. doi: 10.1016/j.jcin.2010.01.015.
PubMed 20488411
Naghavi M, Libby P, Falk E, Casscells SW, Litovsky S, Rumberger J, Badimon JJ, Stefanadis C, Moreno P, Pasterkamp G, Fayad Z, Stone PH, Waxman S, Raggi P, Madjid M, Zarrabi A, Burke A, Yuan C, Fitzgerald PJ, Siscovick DS, de Korte CL, Aikawa M, Juhani Airaksinen KE, Assmann G, Becker CR, Chesebro JH, Farb A, Galis ZS, Jackson C, Jang IK, Koenig W, Lodder RA, March K, Demirovic J, Navab M, Priori SG, Rekhter MD, Bahr R, Grundy SM, Mehran R, Colombo A, Boerwinkle E, Ballantyne C, Insull W Jr, Schwartz RS, Vogel R, Serruys PW, Hansson GK, Faxon DP, Kaul S, Drexler H, Greenland P, Muller JE, Virmani R, Ridker PM, Zipes DP, Shah PK, Willerson JT. From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: Part I. Circulation. 2003 Oct 7;108(14):1664-72. doi: 10.1161/01.CIR.0000087480.94275.97.
PubMed 14530185
Naghavi M, Libby P, Falk E, Casscells SW, Litovsky S, Rumberger J, Badimon JJ, Stefanadis C, Moreno P, Pasterkamp G, Fayad Z, Stone PH, Waxman S, Raggi P, Madjid M, Zarrabi A, Burke A, Yuan C, Fitzgerald PJ, Siscovick DS, de Korte CL, Aikawa M, Airaksinen KE, Assmann G, Becker CR, Chesebro JH, Farb A, Galis ZS, Jackson C, Jang IK, Koenig W, Lodder RA, March K, Demirovic J, Navab M, Priori SG, Rekhter MD, Bahr R, Grundy SM, Mehran R, Colombo A, Boerwinkle E, Ballantyne C, Insull W Jr, Schwartz RS, Vogel R, Serruys PW, Hansson GK, Faxon DP, Kaul S, Drexler H, Greenland P, Muller JE, Virmani R, Ridker PM, Zipes DP, Shah PK, Willerson JT. From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: Part II. Circulation. 2003 Oct 14;108(15):1772-8. doi: 10.1161/01.CIR.0000087481.55887.C9.
PubMed 14557340
Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.
PubMed 33714389
Goldstein JA, Grines C, Fischell T, Virmani R, Rizik D, Muller J, Dixon SR. Coronary embolization following balloon dilation of lipid-core plaques. JACC Cardiovasc Imaging. 2009 Dec;2(12):1420-4. doi: 10.1016/j.jcmg.2009.10.003. No abstract available.
PubMed 20083078
Gardner CM, Tan H, Hull EL, Lisauskas JB, Sum ST, Meese TM, Jiang C, Madden SP, Caplan JD, Burke AP, Virmani R, Goldstein J, Muller JE. Detection of lipid core coronary plaques in autopsy specimens with a novel catheter-based near-infrared spectroscopy system. JACC Cardiovasc Imaging. 2008 Sep;1(5):638-48. doi: 10.1016/j.jcmg.2008.06.001.
PubMed 19356494
Anderson JL, Karagounis LA, Becker LC, Sorensen SG, Menlove RL. TIMI perfusion grade 3 but not grade 2 results in improved outcome after thrombolysis for myocardial infarction. Ventriculographic, enzymatic, and electrocardiographic evidence from the TEAM-3 Study. Circulation. 1993 Jun;87(6):1829-39. doi: 10.1161/01.cir.87.6.1829.
PubMed 8504495
Ndrepepa G, Mehilli J, Schulz S, Iijima R, Keta D, Byrne RA, Pache J, Seyfarth M, Schomig A, Kastrati A. Prognostic significance of epicardial blood flow before and after percutaneous coronary intervention in patients with acute coronary syndromes. J Am Coll Cardiol. 2008 Aug 12;52(7):512-7. doi: 10.1016/j.jacc.2008.05.009.
PubMed 18687242
Mehta RH, Ou FS, Peterson ED, Shaw RE, Hillegass WB Jr, Rumsfeld JS, Roe MT; American College of Cardiology-National Cardiovascular Database Registry Investigators. Clinical significance of post-procedural TIMI flow in patients with cardiogenic shock undergoing primary percutaneous coronary intervention. JACC Cardiovasc Interv. 2009 Jan;2(1):56-64. doi: 10.1016/j.jcin.2008.10.006.
PubMed 19463399
Zhao JL, Yang YJ, Zhang YH, Pei WD, Sun YH, Chen JL, Gao RL. Chronic pretreatment of ACEI reduces no-reflow in patients with acute myocardial infarction treated with primary angioplasty. Clin Cardiol. 2007 Mar;30(3):130-4. doi: 10.1002/clc.20060.
PubMed 17385720
Su Q, Li L, Liu Y. Short-term effect of verapamil on coronary no-reflow associated with percutaneous coronary intervention in patients with acute coronary syndrome: a systematic review and meta-analysis of randomized controlled trials. Clin Cardiol. 2013 Aug;36(8):E11-6. doi: 10.1002/clc.22143. Epub 2013 Jun 7.
PubMed 23749333

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All No-Reflow Phenomenon trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label, Parallel-group Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT reductioN Of decREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease
ClinicalTrials.gov ID: NCT05427786
Acronym / sponsor ID: PREVENT NO-REFLOW
Conditions: No-Reflow Phenomenon, Coronary Artery Disease, Percutaneous Coronary Intervention
Keywords: Nicorandil, No-reflow phenomenon, lipid core burden index, near-infrared spectroscopy
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 458 participants (estimated)
Lead sponsor: Korea University Anam HospitalUniversity, hospital or other
Collaborators: Hanyang University Seoul Hospital, InjeUniversityIlsanPaikHospital, Ajou University School of Medicine
Study start: 14 Dec 2022 (actual)
Primary completion: May 2027 (estimated)
Study completion: May 2028 (estimated)
First posted: 22 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pre-PCI IC Nicorandil	Experimental	Drug: NicorandilIf the lipid core burden index at the main lesion site on vascular ultrasound exceeds 353, randomization was performed. Nicorandil group will be administrated 8cc or more of the prescribed drug (Nicroandil) according to randomization into the coronary artery before starting balloon therapy.
Standard PCI	No intervention	–If the lipid core burden index at the main lesion site on vascular ultrasound exceeds 353, randomization was performed. Standard PCI group will be performed coronary intervention including starting balloon therapy without pre-administrated nicorandil.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Over 19 years old
Patients who agree to the study plan and clinical follow-up plan, voluntarily decide to participate in this study, and consent in writing to the consent to use information
Patients who underwent NIRS-IVUS guided coronary stent surgery for coronary artery disease
maxLCBI4mm ≥354 in the culprit lesion measured by NIRS-IVUS

Key exclusion criteria (6 listed)

Patients with TIMI ≤ 2 before coronary intervention
Subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel And contrast agents (however, even a subject who is hypersensitive to contrast agents can register if they can be controlled by steroids and pheniramine, except for known anaphylaxis.)
Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
Subjects who plan to have surgery to stop antiplatelet drugs within 6 months from registration
Those whose surviving life is expected to be less than 1 year

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NicorandilAdminister 8cc or more of the prescribed drug according to randomization into the coronary artery before starting balloon therapy. The stent treatment method follows the standard treatment method.	Drug	Pre-PCI IC Nicorandil

Primary outcome

Occurrence of decreased TIMI flow
Time frame: during procedure
occurrence of decreased TIMI flow (0,1,2) during the index procedure Grade 0-No perfusion Grade 1-Penetration without perfusion Grade 2-Partial perfusion but not reach complete perfusion Grade 3-Complete perfusion;; antegrade flow into the bed distal to the obstruction occurs as promptly as antegrade flow into the bed proximal to the obstruction, and clearance of contrast material from the involved bed is as rapid as clearance from an uninvolved bed in the same vessel or the opposite artery.

9 secondary outcomes

Change of cardiac biomarker level after intervention
Time frame: 1 month
Change of cardiac biomarker level after intervention
Time frame: 1 month
Change of cardiac biomarker level after intervention
Time frame: 1 month
Change of cardiac biomarker level after intervention
Time frame: 1 month
patient-oriented composite end point
Time frame: 1 year
Percentage of All cause mortality
Time frame: 1 year
Percentage of cardiac death
Time frame: 1 year
Percentage of myocardial infarction
Time frame: 1 year
Percentage of revascularization
Time frame: 1 year

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Background: PubMed 8232430GUSTO Angiographic Investigators. The effects of tissue plasminogen activator, streptokinase, or both on coronary-artery patency, ventricular function, and survival after acute myocardial infarction. N Engl J Med. 1993 Nov 25;329(22):1615-22. doi: 10.1056/NEJM199311253292204.
Background: PubMed 11028471Morishima I, Sone T, Okumura K, Tsuboi H, Kondo J, Mukawa H, Matsui H, Toki Y, Ito T, Hayakawa T. Angiographic no-reflow phenomenon as a predictor of adverse long-term outcome in patients treated with percutaneous transluminal coronary angioplasty for first acute myocardial infarction. J Am Coll Cardiol. 2000 Oct;36(4):1202-9. doi: 10.1016/s0735-1097(00)00865-2.
Background: PubMed 8205658Piana RN, Paik GY, Moscucci M, Cohen DJ, Gibson CM, Kugelmass AD, Carrozza JP Jr, Kuntz RE, Baim DS. Incidence and treatment of 'no-reflow' after percutaneous coronary intervention. Circulation. 1994 Jun;89(6):2514-8. doi: 10.1161/01.cir.89.6.2514.
Background: PubMed 23111142Harrison RW, Aggarwal A, Ou FS, Klein LW, Rumsfeld JS, Roe MT, Wang TY; American College of Cardiology National Cardiovascular Data Registry. Incidence and outcomes of no-reflow phenomenon during percutaneous coronary intervention among patients with acute myocardial infarction. Am J Cardiol. 2013 Jan 15;111(2):178-84. doi: 10.1016/j.amjcard.2012.09.015. Epub 2012 Oct 27.
Background: PubMed 20488411Endo M, Hibi K, Shimizu T, Komura N, Kusama I, Otsuka F, Mitsuhashi T, Iwahashi N, Okuda J, Tsukahara K, Kosuge M, Ebina T, Umemura S, Kimura K. Impact of ultrasound attenuation and plaque rupture as detected by intravascular ultrasound on the incidence of no-reflow phenomenon after percutaneous coronary intervention in ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2010 May;3(5):540-9. doi: 10.1016/j.jcin.2010.01.015.
Background: PubMed 14530185Naghavi M, Libby P, Falk E, Casscells SW, Litovsky S, Rumberger J, Badimon JJ, Stefanadis C, Moreno P, Pasterkamp G, Fayad Z, Stone PH, Waxman S, Raggi P, Madjid M, Zarrabi A, Burke A, Yuan C, Fitzgerald PJ, Siscovick DS, de Korte CL, Aikawa M, Juhani Airaksinen KE, Assmann G, Becker CR, Chesebro JH, Farb A, Galis ZS, Jackson C, Jang IK, Koenig W, Lodder RA, March K, Demirovic J, Navab M, Priori SG, Rekhter MD, Bahr R, Grundy SM, Mehran R, Colombo A, Boerwinkle E, Ballantyne C, Insull W Jr, Schwartz RS, Vogel R, Serruys PW, Hansson GK, Faxon DP, Kaul S, Drexler H, Greenland P, Muller JE, Virmani R, Ridker PM, Zipes DP, Shah PK, Willerson JT. From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: Part I. Circulation. 2003 Oct 7;108(14):1664-72. doi: 10.1161/01.CIR.0000087480.94275.97.
Background: PubMed 14557340Naghavi M, Libby P, Falk E, Casscells SW, Litovsky S, Rumberger J, Badimon JJ, Stefanadis C, Moreno P, Pasterkamp G, Fayad Z, Stone PH, Waxman S, Raggi P, Madjid M, Zarrabi A, Burke A, Yuan C, Fitzgerald PJ, Siscovick DS, de Korte CL, Aikawa M, Airaksinen KE, Assmann G, Becker CR, Chesebro JH, Farb A, Galis ZS, Jackson C, Jang IK, Koenig W, Lodder RA, March K, Demirovic J, Navab M, Priori SG, Rekhter MD, Bahr R, Grundy SM, Mehran R, Colombo A, Boerwinkle E, Ballantyne C, Insull W Jr, Schwartz RS, Vogel R, Serruys PW, Hansson GK, Faxon DP, Kaul S, Drexler H, Greenland P, Muller JE, Virmani R, Ridker PM, Zipes DP, Shah PK, Willerson JT. From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: Part II. Circulation. 2003 Oct 14;108(15):1772-8. doi: 10.1161/01.CIR.0000087481.55887.C9.
Background: PubMed 33714389Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.
Background: PubMed 20083078Goldstein JA, Grines C, Fischell T, Virmani R, Rizik D, Muller J, Dixon SR. Coronary embolization following balloon dilation of lipid-core plaques. JACC Cardiovasc Imaging. 2009 Dec;2(12):1420-4. doi: 10.1016/j.jcmg.2009.10.003. No abstract available.
Background: PubMed 19356494Gardner CM, Tan H, Hull EL, Lisauskas JB, Sum ST, Meese TM, Jiang C, Madden SP, Caplan JD, Burke AP, Virmani R, Goldstein J, Muller JE. Detection of lipid core coronary plaques in autopsy specimens with a novel catheter-based near-infrared spectroscopy system. JACC Cardiovasc Imaging. 2008 Sep;1(5):638-48. doi: 10.1016/j.jcmg.2008.06.001.
Background: PubMed 8504495Anderson JL, Karagounis LA, Becker LC, Sorensen SG, Menlove RL. TIMI perfusion grade 3 but not grade 2 results in improved outcome after thrombolysis for myocardial infarction. Ventriculographic, enzymatic, and electrocardiographic evidence from the TEAM-3 Study. Circulation. 1993 Jun;87(6):1829-39. doi: 10.1161/01.cir.87.6.1829.
Background: PubMed 18687242Ndrepepa G, Mehilli J, Schulz S, Iijima R, Keta D, Byrne RA, Pache J, Seyfarth M, Schomig A, Kastrati A. Prognostic significance of epicardial blood flow before and after percutaneous coronary intervention in patients with acute coronary syndromes. J Am Coll Cardiol. 2008 Aug 12;52(7):512-7. doi: 10.1016/j.jacc.2008.05.009.
Individual participant dataSharing planned: No. The data generated in this study is available from the corresponding author(s) upon reasonable request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Korea University Anam Hospital

Seoul, South Korea

8229205445

joonletter@hanmail.net

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nicorandil in people with No-Reflow Phenomenon and Coronary Artery Disease, run by Korea University Anam Hospital at 1 site in South Korea.

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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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 South Korea. 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. 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of decreased TIMI flow (time frame: during procedure). 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 NCT05427786, which also lists 21 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 8 Sep 2026.