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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05427786
• Other study ID #: PREVENT NO-REFLOW
• Status: Recruiting
• Phase: Phase 4
• Start date: December 14, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• No-Reflow Phenomenon
• Percutaneous Coronary Intervention

Intervention

Drug:
• Nicorandil
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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (21)

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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. — View Citation

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association between lipid profile and lipid core burden index	Correlation among LDL-cholesterol, lipoprotein(a), pre-procedural LCBi max, Post-procedural LCBi, LCBi total burden	6 month
Primary	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.	during procedure
Secondary	Change of cardiac biomarker level after intervention	level change of CPK	1 month
Secondary	Change of cardiac biomarker level after intervention	level change of CK-MB	1 month
Secondary	Change of cardiac biomarker level after intervention	level change of Troponin T	1 month
Secondary	Change of cardiac biomarker level after intervention	level change of Troponin I	1 month
Secondary	patient-oriented composite end point	composite of all cause mortality, any myocardial infarction, and any revascularization	1 year
Secondary	Percentage of All cause mortality		1 year
Secondary	Percentage of cardiac death		1 year
Secondary	Percentage of myocardial infarction		1 year
Secondary	Percentage of revascularization		1 year