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

Phase 4

Recruiting

• Conditions: No-Reflow Phenomenon; Coronary Artery Disease; Percutaneous Coronary Intervention
• Interventions: Drug: Nicorandil

• Registration Number: NCT05427786
• Lead Sponsor: Korea University Anam Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Study Start: 2022-12-14
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-PCI IC Nicorandil	Nicorandil	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of decreased TIMI flow	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.

Secondary Outcome Measures

Name	Time	Method
Change of cardiac biomarker level after intervention	1 month	level change of Troponin I
patient-oriented composite end point	1 year	composite of all cause mortality, any myocardial infarction, and any revascularization
Percentage of All cause mortality	1 year
Percentage of cardiac death	1 year
Percentage of myocardial infarction	1 year
Percentage of revascularization	1 year

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of