Clinical trial NCT04665648: Clinical Efficacy and SAfety of Intravenous Infusion of Nicorandil During Primary Percutaneous Coronary Intervention
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ST Elevation Myocardial Infarction
Percutaneous Coronary Intervention
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 18-80 years;
* acute ST-segment elevation myocardial infarction within 12 hours of symptom onset;

Exclusion Criteria:

* 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;
* contraindicated or intolerable to nicorandil;
* pregnant or lactation period;
* patients with an estimated survival time of less than 1 year.

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 12 month after primary PCI
Secondary outcomes:
measure: Rate of slow re-flow/no-reflow
timeFrame: 3 minutes after primary PCI
measure: Rate fo complete ST-segment resolution
timeFrame: 2 hours after primary PCI
measure: Cardiac death
timeFrame: 12 months after primary PCI
measure: Myocardial reinfarction
timeFrame: 12 months after primary PCI
measure: Target vessel revascularization
timeFrame: 12 months after primary PCI
measure: Unplanned hospitalization for heart failure
timeFrame: 12 months after primary PCI
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Zhongshan Hospital, Fudan University, Shanghai, China
name: Junbo Ge
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.