Clinical Efficacy and SAfety of Intravenous Infusion of Nicorandil During Primary Percutaneous Coronary Intervention
NCT ID: NCT04665648
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1500 participants
INTERVENTIONAL
2021-06-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment arm
Patients who received intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention
Nicorandil
6 mg nicorandil iv. just before coronary intervention, 6mg/h ivgtt. up to 48h after coronary intervention
Placebo arm
Patients who received intravenous placebo before and after reperfusion with primary primary percutaneous coronary intervention
Placebo
placebo iv. just before coronary intervention, ivgtt. up to 48h after coronary intervention
Interventions
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Nicorandil
6 mg nicorandil iv. just before coronary intervention, 6mg/h ivgtt. up to 48h after coronary intervention
Placebo
placebo iv. just before coronary intervention, ivgtt. up to 48h after coronary intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* acute ST-segment elevation myocardial infarction within 12 hours of symptom onset;
Exclusion Criteria
* 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;
* contraindicated or intolerable to nicorandil;
* pregnant or lactation period;
* patients with an estimated survival time of less than 1 year.
18 Years
80 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Ge Junbo
Director, Dept. of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China
Principal Investigators
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Junbo Ge
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Hospital, Fudan University, Shanghai, China
Locations
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Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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ZS-CLEAN
Identifier Type: -
Identifier Source: org_study_id
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