Status:

RECRUITING

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

Lead Sponsor:

Korea University Anam Hospital

Conditions:

No-Reflow Phenomenon

Coronary Artery Disease

Eligibility:

All Genders

19+ years

Phase:

PHASE4

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 v...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 14 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

460 Patients enrolled

Trial Details

Trial ID

NCT05427786

Start Date

December 14 2022

End Date

December 1 2026

Last Update

October 10 2024

Active Locations (1)

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Korea University Anam Hospital

Seoul, South Korea

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 | DecenTrialz