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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Patients who received intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention |
|
| Placebo arm | Placebo Comparator | Patients who received intravenous placebo before and after reperfusion with primary primary percutaneous coronary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicorandil | Drug | 6 mg nicorandil iv. just before coronary intervention, 6mg/h ivgtt. up to 48h after coronary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | cardiac death, myocardial reinfarction, target vessel revascularization, unplanned hospitalization for heart failure | 12 month after primary PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of slow re-flow/no-reflow | final coronary flow in the culprit artery | 3 minutes after primary PCI |
| Rate fo complete ST-segment resolution | ST-segment resolution >50% in ECG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge | Zhongshan Hospital, Fudan University, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17964349 | Result | 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. | |
| 19276198 |
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Starting 6 months after publication of the summary data
IPD collected in this study generated or analyzed during the study are available from the corresponding author by request.
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020108 | Nicorandil |
| ID | Term |
|---|---|
| D009566 | Nitrates |
| D009930 | Organic Chemicals |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
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| Placebo | Drug | placebo iv. just before coronary intervention, ivgtt. up to 48h after coronary intervention |
|
|
| 2 hours after primary PCI |
| Cardiac death | Cardiac death | 12 months after primary PCI |
| Myocardial reinfarction | Myocardial reinfarction | 12 months after primary PCI |
| Target vessel revascularization | Target vessel revascularization | 12 months after primary PCI |
| Unplanned hospitalization for heart failure | Unplanned hospitalization for heart failure | 12 months after primary PCI |
| Result |
| Kawai 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. |
| 24167609 | Result | Wu 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. |
| 34785173 | Derived | Huang 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. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000147 |
| Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |