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A shot of nicorandil before stenting might keep blood flowing

NCT ID NCT05427786

Disease control Sponsor: Korea University Anam Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether injecting nicorandil directly into the coronary artery before balloon angioplasty and stenting can prevent a drop in blood flow, a complication called no-reflow. The study enrolls adults with coronary artery disease who have a high lipid core burden index, a sign of vulnerable plaque. Participants receive either the standard stent procedure plus the nicorandil injection or standard care alone, and researchers compare how often blood flow decreases during the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nicorandil injected directly into the coronary artery before balloon angioplasty and stenting
What this could lead to
If it works, this could offer a simple way to prevent a serious complication during stent procedures, potentially improving outcomes for people with coronary artery disease.
What could go wrong
This is a phase 4 trial, but success is not guaranteed. The drug may not reduce the risk of no-reflow, and there is a small chance of side effects from the injection itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 458 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 4. maxLCBI4mm ≥354 in the culprit lesion measured by NIRS-IVUS 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

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Conditions

The condition(s) this trial relates to.

coronary artery disorder No-Reflow Phenomenon

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease No-reflow phenomenon Percutaneous coronary intervention

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Korea University Anam Hospital

    RECRUITING

    Seoul, South Korea

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