Clinical trial NCT06787430: Effects of Nicorandil on Microvascular Dysfunction in Patients with STEMI Undergoing Primary PCI
Official title: Evaluating the Effects of Nicorandil on Microvascular Dysfunction in Patients with ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: STEMI - ST-segment Elevation Myocardial Infarction
Keywords: Nicorandil
STEMI
microvascular dysfunction
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2025-01-22
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The value of post-PCI AMR
timeFrame: The time immediate after primary PCI
Secondary outcomes:
measure: Prevalence of slow flow or no-flow during procedure
timeFrame: During primary PCI procedure
measure: ST-segment resolution two hours after primary PCI
timeFrame: Two hours after primary PCI
measure: In-hospital peak troponin level
timeFrame: From the enrollment to 7 days after primary PCI
measure: Prevalence of hypotension during procedure
timeFrame: During primary PCI procedure
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.