Clinical Efficacy and sAfety of Intravenous Infusion of Nicorandil During Primary Percutaneous Coronary Intervention

Percutaneous Coronary Intervention Clinical Trial

— CLEAN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04665648
• Other study ID #: ZS-CLEAN
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Fudan University
• Contact: Dong Huang
• Phone: +8613512142875
• Email: huang.dong[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Percutaneous Coronary Intervention
• ST Elevation Myocardial Infarction

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. 2 — View 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 investigato — View 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. eCol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events	cardiac death, myocardial reinfarction, target vessel revascularization, unplanned hospitalization for heart failure	12 month after primary PCI
Secondary	Rate of slow re-flow/no-reflow	final coronary flow in the culprit artery	3 minutes after primary PCI
Secondary	Rate fo complete ST-segment resolution	ST-segment resolution >50% in ECG	2 hours after primary PCI
Secondary	Cardiac death	Cardiac death	12 months after primary PCI
Secondary	Myocardial reinfarction	Myocardial reinfarction	12 months after primary PCI
Secondary	Target vessel revascularization	Target vessel revascularization	12 months after primary PCI
Secondary	Unplanned hospitalization for heart failure	Unplanned hospitalization for heart failure	12 months after primary PCI