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

NCT05427786 | Recruiting Phase 4

• 1 other identifier: PREVENT NO-REFLOW
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

No-Reflow Phenomenon; Coronary Artery Disease; Percutaneous Coronary Intervention

Keywords

Nicorandil; No-reflow phenomenon; lipid core burden index; near-infrared spectroscopy

Outcome Measures

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.

  during procedure

Secondary Outcomes (9)

• Change of cardiac biomarker level after intervention

  1 month

• Change of cardiac biomarker level after intervention

  1 month

• Change of cardiac biomarker level after intervention

  1 month

• Change of cardiac biomarker level after intervention

  1 month

• patient-oriented composite end point

  1 year

Other Outcomes (1)

• Association between lipid profile and lipid core burden index

  6 month

Study Arms (2)

Pre-PCI IC Nicorandil

EXPERIMENTAL

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.

Drug: Nicorandil

Standard PCI

NO INTERVENTION

If the lipid core burden index at the main lesion site on vascular ultrasound exceeds 353, randomization was performed. Standard PCI group will be performed coronary intervention including starting balloon therapy without pre-administrated nicorandil.

Interventions

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.

Pre-PCI IC Nicorandil

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

No-Reflow Phenomenon; Coronary Artery Disease

Interventions

Nicorandil

Condition Hierarchy (Ancestors)

Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A Multi-center, Open Label, Randomized, Parallel-group Study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 22, 2022
• Study Start: December 14, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)