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NCT Number: NCT05427786

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

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.

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Key information

Conditions

No-Reflow Phenomenon Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Ischemia Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Percutaneous Coronary Intervention Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Anam Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Jung Joon Cha, MD, PhD

CONTACT

[email protected]

8229205445

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Occurrence of decreased TIMI flow

    Time frame: 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 outcomes

  1. Change of cardiac biomarker level after intervention

    Time frame: 1 month

    level change of CPK

  2. Change of cardiac biomarker level after intervention

    Time frame: 1 month

    level change of CK-MB

  3. Change of cardiac biomarker level after intervention

    Time frame: 1 month

    level change of Troponin T

  4. Change of cardiac biomarker level after intervention

    Time frame: 1 month

    level change of Troponin I

  5. patient-oriented composite end point

    Time frame: 1 year

    composite of all cause mortality, any myocardial infarction, and any revascularization

  6. Percentage of All cause mortality

    Time frame: 1 year

  7. Percentage of cardiac death

    Time frame: 1 year

  8. Percentage of myocardial infarction

    Time frame: 1 year

  9. Percentage of revascularization

    Time frame: 1 year

Other outcomes

  1. Association between lipid profile and lipid core burden index

    Time frame: 6 month

    Correlation among LDL-cholesterol, lipoprotein(a), pre-procedural LCBi max, Post-procedural LCBi, LCBi total burden

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2022
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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