ST Elevation Myocardial InfarctionPhase 4CLEANNCT04665648
Clinical Efficacy and sAfety of Intravenous Infusion of Nicorandil During Primary Percutaneous Coronary Intervention
A Phase 4 study testing Nicorandil in people with ST Elevation Myocardial Infarction and Percutaneous Coronary Intervention, run by Fudan University at 1 site in China.
Trial summary
The investigators evaluate the efficacy and safety of intravenous administration of nicorandil as adjuncts to reperfusion treatment in acute ST-segment elevation acute myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention
- What is being tested?
- Nicorandil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- 18-80 years;
- acute ST-segment elevation myocardial infarction within 12 hours of symptom onset;
Who cannot join
- systolic blood pressure<100mmHg;
- cardiac shock;
- aortic dissection;
- history of myocardial infarction or percutaneous coronary intervention or coronary artery bypass grafting (<6 month);
- history of the treatment of nicorandil (<6 month);
- history of intravenous nitrates before percutaneous coronary intervention;
Show all 9Show fewer
- contraindicated or intolerable to nicorandil;
- pregnant or lactation period;
- patients with an estimated survival time of less than 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Intravenous Administration of Nicorandil as Adjuncts to Reperfusion Treatment for Acute ST Segment Elevation Myocardial Infarction: a Multi-center Randomized Controlled Trial
The investigators evaluate the efficacy and safety of intravenous administration of nicorandil as adjuncts to reperfusion treatment in acute ST-segment elevation acute myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI).
- Being tested
- Nicorandil, Placebo
- 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
Also called intraveous nicorandil
6 mg nicorandil iv. just before coronary intervention, 6mg/h ivgtt. up to 48h after coronary intervention
PlaceboDrug
Also called intraveous palcebo
placebo iv. just before coronary intervention, ivgtt. up to 48h after coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients who received intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention Receives: Drug: Nicorandil |
| Placebo arm | Placebo comparator | Patients who received intravenous placebo before and after reperfusion with primary primary percutaneous coronary intervention Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
cardiac death, myocardial reinfarction, target vessel revascularization, unplanned hospitalization for heart failure
Measured: 12 month after primary PCI
Secondary outcomes (6)
Rate of slow re-flow/no-reflow
final coronary flow in the culprit artery
Measured: 3 minutes after primary PCI
Rate fo complete ST-segment resolution
ST-segment resolution >50% in ECG
Measured: 2 hours after primary PCI
Cardiac death
Cardiac death
Measured: 12 months after primary PCI
Myocardial reinfarction
Myocardial reinfarction
Measured: 12 months after primary PCI
Target vessel revascularization
Target vessel revascularization
Measured: 12 months after primary PCI
Unplanned hospitalization for heart failure
Unplanned hospitalization for heart failure
Measured: 12 months after primary PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Jun 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ge Junbo, Fudan University
- Investigators
- Junbo Ge, Principal investigator, Zhongshan Hospital, Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665648
- Sponsor's protocol ID
- ZS-CLEAN
- Acronym
- CLEAN
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2020
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kitakaze M, Asakura M, Kim J, Shintani Y, Asanuma H, Hamasaki T, Seguchi O, Myoishi M, Minamino T, Ohara T, Nagai Y, Nanto S, Watanabe K, Fukuzawa S, Hirayama A, Nakamura N, Kimura K, Fujii K, Ishihara M, Saito Y, Tomoike H, Kitamura S; J-WIND investigators. Human atrial natriuretic peptide and nicorandil as adjuncts to reperfusion treatment for acute myocardial infarction (J-WIND): two randomised trials. Lancet. 2007 Oct 27;370(9597):1483-93. doi: 10.1016/S0140-6736(07)61634-1.
PubMed 17964349Kawai Y, Hisamatsu K, Matsubara H, Dan K, Akagi S, Miyaji K, Munemasa M, Fujimoto Y, Kusano KF, Ohe T. Intravenous administration of nicorandil immediately before percutaneous coronary intervention can prevent slow coronary flow phenomenon. Eur Heart J. 2009 Apr;30(7):765-72. doi: 10.1093/eurheartj/ehp077. Epub 2009 Mar 10.
PubMed 19276198Wu M, Huang Z, Xie H, Zhou Z. Nicorandil in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention: a systematic review and meta-analysis. PLoS One. 2013 Oct 22;8(10):e78231. doi: 10.1371/journal.pone.0078231. eCollection 2013.
PubMed 24167609Huang D, Wu H, Lu Y, Liu Q, Cai H, Shen J, Ma L, Yu Z, Zhao S, He S, Peng W, Zhang J, Qian J, Ge J; CLEAN Study Group. Intravenous Nicorandil in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary PCI: The CLEAN Randomized Clinical Trial. J Am Coll Cardiol. 2026 Jul 30:S0735-1097(26)07071-3. doi: 10.1016/j.jacc.2026.07.005. Online ahead of print.
PubMed 42584383Huang D, Wu H, Zhou J, Zhong X, Gao W, Ma Y, Qian J, Ge J. Intravenous nicorandil during primary percutaneous coronary intervention in patients with ST-Elevation myocardial infarction: Rationale and design of the Clinical Efficacy and Safety of Intravenous Nicorandil (CLEAN) trial. Am Heart J. 2022 Feb;244:86-93. doi: 10.1016/j.ahj.2021.11.005. Epub 2021 Nov 14.
PubMed 34785173
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intravenous Administration of Nicorandil as Adjuncts to Reperfusion Treatment for Acute ST Segment Elevation Myocardial Infarction: a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04665648
- Acronym / sponsor ID
- CLEAN / ZS-CLEAN
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 11 Dec 2020 (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.
The investigators evaluate the efficacy and safety of intravenous administration of nicorandil as adjuncts to reperfusion treatment in acute ST-segment elevation acute myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: NicorandilPatients who received intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention |
| Placebo arm | Placebo comparator | Drug: PlaceboPatients who received intravenous placebo before and after reperfusion with primary primary percutaneous coronary intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-80 years;
- acute ST-segment elevation myocardial infarction within 12 hours of symptom onset;
Key exclusion criteria (9 listed)
- systolic blood pressure<100mmHg;
- cardiac shock;
- aortic dissection;
- history of myocardial infarction or percutaneous coronary intervention or coronary artery bypass grafting (<6 month);
- history of the treatment of nicorandil (<6 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 |
|---|---|---|
| NicorandilAlso: intraveous nicorandil6 mg nicorandil iv. just before coronary intervention, 6mg/h ivgtt. up to 48h after coronary intervention | Drug | Treatment arm |
| PlaceboAlso: intraveous palceboplacebo iv. just before coronary intervention, ivgtt. up to 48h after coronary intervention | Drug | Placebo arm |
Primary outcome
Major adverse cardiac events
Time frame: 12 month after primary PCI
cardiac death, myocardial reinfarction, target vessel revascularization, unplanned hospitalization for heart failure
6 secondary outcomes
Rate of slow re-flow/no-reflow
Time frame: 3 minutes after primary PCI
Rate fo complete ST-segment resolution
Time frame: 2 hours after primary PCI
Cardiac death
Time frame: 12 months after primary PCI
Myocardial reinfarction
Time frame: 12 months after primary PCI
Target vessel revascularization
Time frame: 12 months after primary PCI
Unplanned hospitalization for heart failure
Time frame: 12 months after primary PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Results publication: PubMed 17964349Kitakaze M, Asakura M, Kim J, Shintani Y, Asanuma H, Hamasaki T, Seguchi O, Myoishi M, Minamino T, Ohara T, Nagai Y, Nanto S, Watanabe K, Fukuzawa S, Hirayama A, Nakamura N, Kimura K, Fujii K, Ishihara M, Saito Y, Tomoike H, Kitamura S; J-WIND investigators. Human atrial natriuretic peptide and nicorandil as adjuncts to reperfusion treatment for acute myocardial infarction (J-WIND): two randomised trials. Lancet. 2007 Oct 27;370(9597):1483-93. doi: 10.1016/S0140-6736(07)61634-1.
- Results publication: PubMed 19276198Kawai Y, Hisamatsu K, Matsubara H, Dan K, Akagi S, Miyaji K, Munemasa M, Fujimoto Y, Kusano KF, Ohe T. Intravenous administration of nicorandil immediately before percutaneous coronary intervention can prevent slow coronary flow phenomenon. Eur Heart J. 2009 Apr;30(7):765-72. doi: 10.1093/eurheartj/ehp077. Epub 2009 Mar 10.
- Results publication: PubMed 24167609Wu M, Huang Z, Xie H, Zhou Z. Nicorandil in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention: a systematic review and meta-analysis. PLoS One. 2013 Oct 22;8(10):e78231. doi: 10.1371/journal.pone.0078231. eCollection 2013.
- Derived from this study: PubMed 42584383Huang D, Wu H, Lu Y, Liu Q, Cai H, Shen J, Ma L, Yu Z, Zhao S, He S, Peng W, Zhang J, Qian J, Ge J; CLEAN Study Group. Intravenous Nicorandil in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary PCI: The CLEAN Randomized Clinical Trial. J Am Coll Cardiol. 2026 Jul 30:S0735-1097(26)07071-3. doi: 10.1016/j.jacc.2026.07.005. Online ahead of print.
- Derived from this study: PubMed 34785173Huang D, Wu H, Zhou J, Zhong X, Gao W, Ma Y, Qian J, Ge J. Intravenous nicorandil during primary percutaneous coronary intervention in patients with ST-Elevation myocardial infarction: Rationale and design of the Clinical Efficacy and Safety of Intravenous Nicorandil (CLEAN) trial. Am Heart J. 2022 Feb;244:86-93. doi: 10.1016/j.ahj.2021.11.005. Epub 2021 Nov 14.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Junbo Ge principal investigator
Zhongshan Hospital, Fudan University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicorandil in people with ST Elevation Myocardial Infarction and Percutaneous Coronary Intervention, run by Fudan University at 1 site in China.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (time frame: 12 month 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 NCT04665648, which also lists 5 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 11 Mar 2025.