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

NCT06787430 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-03-12

No results posted yet for this study

Summary

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.

Conditions

  • STEMI - ST-segment Elevation Myocardial Infarction

Interventions

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.

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.

Sponsors & Collaborators

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-12-01
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06787430 on ClinicalTrials.gov