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

Phase 4

Completed

• Conditions: ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention
• Interventions: Drug: Placebo; Drug: Nicorandil

• Registration Number: NCT04665648
• Lead Sponsor: Fudan University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-11
• Study Start: 2021-06-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo	Patients who received intravenous placebo before and after reperfusion with primary primary percutaneous coronary intervention
Treatment arm	Nicorandil	Patients who received intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	12 month after primary PCI	cardiac death, myocardial reinfarction, target vessel revascularization, unplanned hospitalization for heart failure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China