Effects of Nicorandil on Microvascular Dysfunction in Patients With STEMI Undergoing Primary PCI (NORMAL)

March 11, 2026 updated by: China National Center for Cardiovascular Diseases

Evaluating the Effects of Nicorandil on Microvascular Dysfunction in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Despite the success of restoration of epicardial blood flow by the primary percutaneous coronary intervention (PPCI), approximately one half of patients with ST-segment elevation myocardial infarction (STEMI) have failed myocardial reperfusion, namely microvascular dysfunction. Previous studies have shown that coronary microvascular damage significantly impacts the prognosis of patients with STEMI. Therefore, restoration of microvascular function is quite important during the PPCI procedures. Recent clinical trials found that nicorandil, a hybrid ATP-sensitive potassium channel opening agent, improved microvascular function, prevented no-reflow phenomenon, and had beneficial cardioprotective effects in patients receiving PPCI. However, there was a lack of evidence on the protective effects of nicorandil on microvascular function. The coronary angiography-derived IMR (AMR) is a novel wire-free technology developed for fast computation of IMR in patients undergoing coronary angiography, thereby enabling the quantification of coronary microcirculation of patients. This study is aimed to investigate the effects of nicorandil on microvascular dysfunction as evaluated by AMR in patients with STEMI.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is aimed to investigate the effects of nicorandil on microvascular dysfunction as evaluated by AMR in patients with STEMI.

This study is a prospective, single-center, double-blind, randomized controlled study, evaluate the effects of nicorandil on nicorandil on microvascular dysfunction in patients with STEMI undergoing primary PCI.

The inclusion criteria are as following: Age between 18-80; Diagnosis of STEMI and indicating for primary PCI; Diagnostic coronary angiography showed definite culprit vessel and primary PCI was planned to treat the culprit vessel; Reference vessel diameter of culprit vessel was greater than 2.0 mm; There was no flow-limiting stenosis for the non-culprit vessels; Understand the aim of this trial and agree to sign the informed consent form.

The exclusion criteria are as following: Acute in- stent thrombosis or in-stent stenosis lesions of culprit vessel; Balloon angioplasty rather than stent was planned for the culprit vessel; Allergic to nicorandil or systolic arterial pressure was less than 85mmHg before procedure; Vessel with twisted shape that was unable to be measured using AMR; Oral or intravenous use of nicorandil within one month; Cardiac shock needing mechanical support; Severely hepatic dysfunction; Severely renal failure needing hemodialysis; Contraindicated for coronary angiography or primary PCI; Culprit vessels of left main or graft vessels; Pregnant or nursing; Others that investigators think should excluded.

Patients were randomized into nicorandil group and control group with ratio of 1:1. In the nicorandil group, intracoronary nicorandil 3mg dissolved in 3ml saline was given within 30 seconds at two time points, one was when the guidewire or ballon passed the lesion and the blood flow was regained, and another was the time before the stent was implanted. In the control group, 3ml saline was given intracoronary through the guiding catheter within 30 seconds at the same time points in nicorandil group. All the procedure details including strategies, decision of intravascular imaging, other medications during procedures were decided by operators.

The angiography-derived microcirculatory resistance (AMR) is a wire-free and adenosine-free index, which aims at providing a valid alternative to invasive wire-based IMR assessment.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18-80
  • Diagnosis of STEMI and indicating for primary PCI
  • Diagnostic coronary angiography showed definite culprit vessel and primary PCI was planned to treat the culprit vessel.
  • Reference vessel diameter of culprit vessel was greater than 2.0 mm
  • There was no flow-limiting stenosis for the non-culprit vessels.
  • Understand the aim of this trial and agree to sign the informed consent form.

Exclusion Criteria:

  • Acute in- stent thrombosis or in-stent stenosis lesions of culprit vessel.
  • Balloon angioplasty rather than stent was planned for the culprit vessel.
  • Allergic to nicorandil or systolic arterial pressure was less than 85mmHg before procedure
  • Vessel with twisted shape that was unable to be measured using AMR
  • Oral or intravenous use of nicorandil within one month.
  • Cardiac shock needing mechanical support.
  • Severely hepatic dysfunction.
  • Severely renal failure needing hemodialysis.
  • Contraindicated for coronary angiography or primary PCI.
  • Culprit vessels of left main or graft vessels.
  • Pregnant or nursing.
  • Others that investigators think should excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicorandil group
In the nicorandil group, intracoronary nicorandil 3mg dissolved in 3ml saline was given within 30 seconds at two time points, one was when the guidewire or ballon passed the lesion and the blood flow was regained, and another was the time before the stent was implanted.
Drug: nicorandil
In the nicorandil group, intracoronary nicorandil 3mg dissolved in 3ml saline was given within 30 seconds at two time points, one was when the guidewire or ballon passed the lesion and the blood flow was regained, and another was the time before the stent was implanted.
Placebo Comparator: Control group
In the control group, 3ml saline was given within 30 seconds at the same time points in nicorandil group.
Drug: Saline (NaCl 0,9 %) (placebo)
In the control group, 3ml saline was given intracoronary through the guiding catheter within 30 seconds at the same time points in nicorandil group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The value of post-PCI AMR
Time Frame: The time immediate after primary PCI
AMR was obtained by analyzing the last angiography video of culprit vessel after procedure. AMR was analyzed by sophisticated technicians who were unaware of the group division.
The time immediate after primary PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of slow flow or no-flow during procedure
Time Frame: During primary PCI procedure
During primary PCI procedure
ST-segment resolution two hours after primary PCI
Time Frame: Two hours after primary PCI
Analyze the elevated leads of EKG two hours after primary PCI
Two hours after primary PCI
In-hospital peak troponin level
Time Frame: From the enrollment to 7 days after primary PCI
From the enrollment to 7 days after primary PCI
Prevalence of hypotension during procedure
Time Frame: During primary PCI procedure
Prevalence of hypotension during procedure: defined by systolic arterial pressure less than 85mmHg or systolic arterial pressure dropped greater than 40mmHg after the use of nicorandil and lasted for 15 minutes.
During primary PCI procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 26, 2024

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-2375

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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