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

Primary Purpose

ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nicorandil
Placebo
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment arm

Placebo arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of slow re-flow/no-reflow
final coronary flow in the culprit artery
Rate fo complete ST-segment resolution
ST-segment resolution >50% in ECG
Cardiac death
Cardiac death
Myocardial reinfarction
Myocardial reinfarction
Target vessel revascularization
Target vessel revascularization
Unplanned hospitalization for heart failure
Unplanned hospitalization for heart failure

Full Information

First Posted
December 2, 2020
Last Updated
September 13, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04665648
Brief Title
Clinical Efficacy and sAfety of Intravenous Infusion of Nicorandil During Primary Percutaneous Coronary Intervention
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Patients who received intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Patients who received intravenous placebo before and after reperfusion with primary primary percutaneous coronary intervention
Intervention Type
Drug
Intervention Name(s)
Nicorandil
Other Intervention Name(s)
intraveous nicorandil
Intervention Description
6 mg nicorandil iv. just before coronary intervention, 6mg/h ivgtt. up to 48h after coronary intervention
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
intraveous palcebo
Intervention Description
placebo iv. just before coronary intervention, ivgtt. up to 48h after coronary intervention
Primary Outcome Measure Information:
Title
Major adverse cardiac events
Description
cardiac death, myocardial reinfarction, target vessel revascularization, unplanned hospitalization for heart failure
Time Frame
12 month after primary PCI
Secondary Outcome Measure Information:
Title
Rate of slow re-flow/no-reflow
Description
final coronary flow in the culprit artery
Time Frame
3 minutes after primary PCI
Title
Rate fo complete ST-segment resolution
Description
ST-segment resolution >50% in ECG
Time Frame
2 hours after primary PCI
Title
Cardiac death
Description
Cardiac death
Time Frame
12 months after primary PCI
Title
Myocardial reinfarction
Description
Myocardial reinfarction
Time Frame
12 months after primary PCI
Title
Target vessel revascularization
Description
Target vessel revascularization
Time Frame
12 months after primary PCI
Title
Unplanned hospitalization for heart failure
Description
Unplanned hospitalization for heart failure
Time Frame
12 months after primary PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Huang
Phone
+8613512142875
Email
huang.dong@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junbo Ge
Organizational Affiliation
Zhongshan Hospital, Fudan University, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Huang
Phone
13512142875
Email
huang.dong@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share 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.
Citations:
PubMed Identifier
17964349
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. Erratum In: Lancet. 2008 Dec 22;370(9605):2102.
Results Reference
result
PubMed Identifier
19276198
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.
Results Reference
result
PubMed Identifier
24167609
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.
Results Reference
result
PubMed Identifier
34785173
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.
Results Reference
derived

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

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