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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorKorea University Anam Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nicorandil

    Drug

    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.

Treatment groups

458 Participants
are divided into 2 treatment groups
Group A: Pre-PCI IC NicorandilExperimental treatment 1 intervention
Group B: Standard PCINo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
during procedure

Secondary outcomes

1

Change of cardiac biomarker level after intervention

level change of CPK

Time frame
1 month
2

Change of cardiac biomarker level after intervention

level change of CK-MB

Time frame
1 month
3

Change of cardiac biomarker level after intervention

level change of Troponin T

Time frame
1 month
4

Change of cardiac biomarker level after intervention

level change of Troponin I

Time frame
1 month

Other outcomes

1

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

Time frame
6 month

Sponsors and contacts

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Korea University Anam Hospital

Lead sponsor

Hanyang University Seoul Hospital

Collaborator

InjeUniversityIlsanPaikHospital

Collaborator

Ajou University School of Medicine

Collaborator