search
Back to results

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

Primary Purpose

No-Reflow Phenomenon, Coronary Artery Disease, Percutaneous Coronary Intervention

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nicorandil
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for No-Reflow Phenomenon focused on measuring Nicorandil, No-reflow phenomenon, lipid core burden index, near-infrared spectroscopy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Over 19 years old
  2. 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
  3. Patients who underwent NIRS-IVUS guided coronary stent surgery for coronary artery disease

Exclusion Criteria:

  1. Patients with TIMI ≤ 2 before coronary intervention
  2. 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.)
  3. Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
  4. Subjects who plan to have surgery to stop antiplatelet drugs within 6 months from registration
  5. Those whose surviving life is expected to be less than 1 year
  6. Subjects who visited the hospital due to cardiogenic shock and are predicted to have low survival probability based on medical judgment

Sites / Locations

  • Korea University Anam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pre-PCI IC Nicorandil

Standard PCI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 14, 2022
Last Updated
March 12, 2023
Sponsor
Korea University Anam Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05427786
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
No-Reflow Phenomenon, Coronary Artery Disease, Percutaneous Coronary Intervention
Keywords
Nicorandil, No-reflow phenomenon, lipid core burden index, near-infrared spectroscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
A Multi-center, Open Label, Randomized, Parallel-group Study
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-PCI IC Nicorandil
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard PCI
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicorandil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of decreased TIMI flow
Description
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.
Time Frame
during procedure
Secondary Outcome Measure Information:
Title
Change of cardiac biomarker level after intervention
Description
level change of CPK
Time Frame
1 month
Title
Change of cardiac biomarker level after intervention
Description
level change of CK-MB
Time Frame
1 month
Title
Change of cardiac biomarker level after intervention
Description
level change of Troponin T
Time Frame
1 month
Title
Change of cardiac biomarker level after intervention
Description
level change of Troponin I
Time Frame
1 month
Title
patient-oriented composite end point
Description
composite of all cause mortality, any myocardial infarction, and any revascularization
Time Frame
1 year
Title
Percentage of All cause mortality
Time Frame
1 year
Title
Percentage of cardiac death
Time Frame
1 year
Title
Percentage of myocardial infarction
Time Frame
1 year
Title
Percentage of revascularization
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Association between lipid profile and lipid core burden index
Description
Correlation among LDL-cholesterol, lipoprotein(a), pre-procedural LCBi max, Post-procedural LCBi, LCBi total burden
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Joon Cha, MD, PhD
Phone
8229205445
Email
joonletter@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data generated in this study is available from the corresponding author(s) upon reasonable request.
Citations:
PubMed Identifier
8232430
Citation
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. Erratum In: N Engl J Med 1994 Feb 17;330(7):516.
Results Reference
background
PubMed Identifier
11028471
Citation
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.
Results Reference
background
PubMed Identifier
8205658
Citation
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.
Results Reference
background
PubMed Identifier
23111142
Citation
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.
Results Reference
background
PubMed Identifier
20488411
Citation
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.
Results Reference
background
PubMed Identifier
14530185
Citation
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.
Results Reference
background
PubMed Identifier
14557340
Citation
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.
Results Reference
background
PubMed Identifier
33714389
Citation
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.
Results Reference
background
PubMed Identifier
20083078
Citation
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.
Results Reference
background
PubMed Identifier
19356494
Citation
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.
Results Reference
background
PubMed Identifier
8504495
Citation
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.
Results Reference
background
PubMed Identifier
18687242
Citation
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.
Results Reference
background
PubMed Identifier
19463399
Citation
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.
Results Reference
background
PubMed Identifier
17385720
Citation
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.
Results Reference
background
PubMed Identifier
23749333
Citation
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.
Results Reference
background
PubMed Identifier
7634481
Citation
Falk E, Shah PK, Fuster V. Coronary plaque disruption. Circulation. 1995 Aug 1;92(3):657-71. doi: 10.1161/01.cir.92.3.657. No abstract available.
Results Reference
background
PubMed Identifier
22253357
Citation
Madder RD, Smith JL, Dixon SR, Goldstein JA. Composition of target lesions by near-infrared spectroscopy in patients with acute coronary syndrome versus stable angina. Circ Cardiovasc Interv. 2012 Feb 1;5(1):55-61. doi: 10.1161/CIRCINTERVENTIONS.111.963934. Epub 2012 Jan 17.
Results Reference
background
PubMed Identifier
10662756
Citation
Topol EJ, Yadav JS. Recognition of the importance of embolization in atherosclerotic vascular disease. Circulation. 2000 Feb 8;101(5):570-80. doi: 10.1161/01.cir.101.5.570. No abstract available.
Results Reference
background
PubMed Identifier
12923001
Citation
Falk E, Thuesen L. Pathology of coronary microembolisation and no reflow. Heart. 2003 Sep;89(9):983-5. doi: 10.1136/heart.89.9.983. No abstract available.
Results Reference
background
PubMed Identifier
31570255
Citation
Waksman R, Di Mario C, Torguson R, Ali ZA, Singh V, Skinner WH, Artis AK, Cate TT, Powers E, Kim C, Regar E, Wong SC, Lewis S, Wykrzykowska J, Dube S, Kazziha S, van der Ent M, Shah P, Craig PE, Zou Q, Kolm P, Brewer HB, Garcia-Garcia HM; LRP Investigators. Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet. 2019 Nov 2;394(10209):1629-1637. doi: 10.1016/S0140-6736(19)31794-5. Epub 2019 Sep 27. Erratum In: Lancet. 2019 Nov 2;394(10209):1618.
Results Reference
background
PubMed Identifier
28531282
Citation
Schuurman AS, Vroegindewey M, Kardys I, Oemrawsingh RM, Cheng JM, de Boer S, Garcia-Garcia HM, van Geuns RJ, Regar ES, Daemen J, van Mieghem NM, Serruys PW, Boersma E, Akkerhuis KM. Near-infrared spectroscopy-derived lipid core burden index predicts adverse cardiovascular outcome in patients with coronary artery disease during long-term follow-up. Eur Heart J. 2018 Jan 21;39(4):295-302. doi: 10.1093/eurheartj/ehx247.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs