Back to resultsA 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
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
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
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
NCT ID
NCT05427786
First Posted
June 14, 2022
Last Updated
March 12, 2023
Sponsor
Korea University Anam Hospital
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.
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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
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