Effects of Nicorandil on Microvascular Dysfunction in Patients With STEMI Undergoing Primary PCI (NCT06787430) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Effects of Nicorandil on Microvascular Dysfunction in Patients With STEMI Undergoing Primary PCI
170 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The value of post-PCI AMR
Timeframe: The time immediate after primary PCI
Trial details
NCT IDNCT06787430
SponsorChina National Center for Cardiovascular Diseases