STEMI - ST-segment Elevation Myocardial InfarctionPhase 4NORMALNCT06787430
Effects of Nicorandil on Microvascular Dysfunction in Patients With STEMI Undergoing Primary PCI
A Phase 4 study testing nicorandil in people with STEMI - ST-segment Elevation Myocardial Infarction, run by China National Center for Cardiovascular Diseases.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- STEMI - ST-segment Elevation Myocardial Infarction
- What is being tested?
- nicorandil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- nicorandil, Saline (NaCl 0,9 %) (placebo)
- Keywords
- Nicorandil, STEMI, microvascular dysfunction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicorandilDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The time immediate after primary PCI
Secondary outcomes (4)
Prevalence of slow flow or no-flow during procedure
Measured: During primary PCI procedure
ST-segment resolution two hours after primary PCI
Analyze the elevated leads of EKG two hours after primary PCI
Measured: Two hours after primary PCI
In-hospital peak troponin level
Measured: From the enrollment to 7 days after primary PCI
Prevalence of hypotension during 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.
Measured: During primary PCI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for STEMI - ST-segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787430
- Sponsor's protocol ID
- 2024-2375
- Acronym
- NORMAL
- Status last verified
- Jul 2025
- First submitted
- 26 Dec 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37319341Hirohata 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.
PubMed 24457276Qian 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.
PubMed 36073634
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Nicorandil on Microvascular Dysfunction in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06787430
- Acronym / sponsor ID
- NORMAL / 2024-2375
- Keywords
- Nicorandil, STEMI, microvascular dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicorandil group | Experimental | Drug: nicorandilIn 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. |
| Control group | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo)In the control group, 3ml saline was given within 30 seconds at the same time points in nicorandil group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nicorandilIn 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 group |
| 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. | Drug | Control group |
Primary outcome
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.
4 secondary outcomes
Prevalence of slow flow or no-flow during procedure
Time frame: During primary PCI procedure
ST-segment resolution two hours after primary PCI
Time frame: Two hours after primary PCI
In-hospital peak troponin level
Time frame: From the enrollment to 7 days after primary PCI
Prevalence of hypotension during procedure
Time frame: During primary PCI procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Results publication: PubMed 37319341Wang 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.
- Results publication: PubMed 24457276Hirohata 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.
- Results publication: PubMed 36073634Qian 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nicorandil in people with STEMI - ST-segment Elevation Myocardial Infarction, run by China National Center for Cardiovascular Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JIANSONG YUAN (+86 13520691041, fwyuannjs@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The value of post-PCI AMR (time frame: The time immediate after primary PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787430, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.