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

March 7, 2025 updated by: Ge Junbo, Fudan University

Impact of Intravenous Administration of Nicorandil As Adjuncts to Reperfusion Treatment for Acute ST Segment Elevation Myocardial Infarction: a Multi-center Randomized Controlled Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm
Patients who received intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention
Drug: Nicorandil
6 mg nicorandil iv. just before coronary intervention, 6mg/h ivgtt. up to 48h after coronary intervention
Other Names:
  • intraveous nicorandil
Placebo Comparator: Placebo arm
Patients who received intravenous placebo before and after reperfusion with primary primary percutaneous coronary intervention
Drug: Placebo
placebo iv. just before coronary intervention, ivgtt. up to 48h after coronary intervention
Other Names:
  • intraveous palcebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events
Time Frame: 12 month after primary PCI
cardiac death, myocardial reinfarction, target vessel revascularization, unplanned hospitalization for heart failure
12 month after primary PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of slow re-flow/no-reflow
Time Frame: 3 minutes after primary PCI
final coronary flow in the culprit artery
3 minutes after primary PCI
Rate fo complete ST-segment resolution
Time Frame: 2 hours after primary PCI
ST-segment resolution >50% in ECG
2 hours after primary PCI
Cardiac death
Time Frame: 12 months after primary PCI
Cardiac death
12 months after primary PCI
Myocardial reinfarction
Time Frame: 12 months after primary PCI
Myocardial reinfarction
12 months after primary PCI
Target vessel revascularization
Time Frame: 12 months after primary PCI
Target vessel revascularization
12 months after primary PCI
Unplanned hospitalization for heart failure
Time Frame: 12 months after primary PCI
Unplanned hospitalization for heart failure
12 months after primary PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Junbo Ge, Zhongshan Hospital, Fudan University, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-CLEAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Starting 6 months after publication of the summary data

IPD Sharing Access Criteria

IPD collected in this study generated or analyzed during the study are available from the corresponding author by request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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