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

Korea University

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Nicorandil

Study type: Interventional

Funder types: Other

Identifiers

NCT05427786

PREVENT NO-REFLOW

Details and patient eligibility

About

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.

Enrollment: 460 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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460 participants in 2 patient groups

Pre-PCI IC Nicorandil

Experimental group

Description:

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.

Treatment:

Drug: Nicorandil

Standard PCI

No Intervention group

Description:

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.