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

NCT06787430 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2024-2375
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Nicorandil; STEMI; microvascular dysfunction

Outcome Measures

Primary Outcomes (1)

• The value of post-PCI AMR

  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 Outcomes (4)

• Prevalence of slow flow or no-flow during procedure

  During primary PCI procedure

• ST-segment resolution two hours after primary PCI

  Two hours after primary PCI

• In-hospital peak troponin level

  From the enrollment to 7 days after primary PCI

• Prevalence of hypotension during procedure

  During primary PCI procedure

Study Arms (2)

Nicorandil group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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)

Interventions

nicorandil DRUG

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.

Nicorandil group

Saline (NaCl 0,9 %) (placebo) DRUG

In the control group, 3ml saline was given intracoronary through the guiding catheter within 30 seconds at the same time points in nicorandil group.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Related Publications (3)

• Wang X, Guo Q, Guo R, Guo Y, Yan Y, Gong W, Zheng W, Wang H, Ai H, Que B, Xu L, Huo Y, Fearon WF, Nie S. Coronary angiography-derived index of microcirculatory resistance and evolution of infarct pathology after ST-segment-elevation myocardial infarction. Eur Heart J Cardiovasc Imaging. 2023 Nov 23;24(12):1640-1652. doi: 10.1093/ehjci/jead141.

  PMID: 37319341 RESULT

• Hirohata A, Yamamoto K, Hirose E, Kobayashi Y, Takafuji H, Sano F, Matsumoto K, Ohara M, Yoshioka R, Takinami H, Ohe T. Nicorandil prevents microvascular dysfunction resulting from PCI in patients with stable angina pectoris: a randomised study. EuroIntervention. 2014 Jan 22;9(9):1050-6. doi: 10.4244/EIJV9I9A178.

  PMID: 24457276 RESULT

• Qian G, Zhang Y, Dong W, Jiang ZC, Li T, Cheng LQ, Zou YT, Jiang XS, Zhou H, A X, Li P, Chen ML, Su X, Tian JW, Shi B, Li ZZ, Wu YQ, Li YJ, Chen YD. Effects of Nicorandil Administration on Infarct Size in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: The CHANGE Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e026232. doi: 10.1161/JAHA.122.026232. Epub 2022 Sep 8.

  PMID: 36073634 RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Nicorandil; Sodium Chloride

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

JIANSONG YUAN

CONTACT

+86 13520691041; fwyuannjs@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 22, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 12, 2026

Record last verified: 2025-07