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

NCT04665648 | Completed Phase 4 DMC

• 1 other identifier: ZS-CLEAN
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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).

Conditions

ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events

  cardiac death, myocardial reinfarction, target vessel revascularization, unplanned hospitalization for heart failure

  12 month after primary PCI

Secondary Outcomes (6)

• Rate of slow re-flow/no-reflow

  3 minutes after primary PCI

• Rate fo complete ST-segment resolution

  2 hours after primary PCI

• Cardiac death

  12 months after primary PCI

• Myocardial reinfarction

  12 months after primary PCI

• Target vessel revascularization

  12 months after primary PCI

Study Arms (2)

Treatment arm

EXPERIMENTAL

Patients who received intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention

Drug: Nicorandil

Placebo arm

PLACEBO COMPARATOR

Patients who received intravenous placebo before and after reperfusion with primary primary percutaneous coronary intervention

Drug: Placebo

Interventions

Nicorandil DRUG

6 mg nicorandil iv. just before coronary intervention, 6mg/h ivgtt. up to 48h after coronary intervention

Also known as: intraveous nicorandil

Treatment arm

Placebo DRUG

placebo iv. just before coronary intervention, ivgtt. up to 48h after coronary intervention

Also known as: intraveous palcebo

Placebo arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years;
• acute ST-segment elevation myocardial infarction within 12 hours of symptom onset;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (4)

• 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.

  PMID: 17964349 BACKGROUND

• 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.

  PMID: 19276198 BACKGROUND

• 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.

  PMID: 24167609 BACKGROUND

• 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.

  PMID: 34785173 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Nicorandil

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Junbo Ge

  Zhongshan Hospital, Fudan University, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Dept. of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 11, 2020
• Study Start: June 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication of the summary data
• Access Criteria: IPD collected in this study generated or analyzed during the study are available from the corresponding author by request.

Locations

CN (1)