Impact of Intravenous Administration of Nicorandil As Adjuncts to Reperfusion Treatment for Acute ST Segment Elevation Myocardial Infarction: a Multi-center Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Nicorandil
- Conditions
- ST Elevation Myocardial Infarction
- Sponsor
- Fudan University
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- Major adverse cardiac events
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Ge Junbo
Director, Dept. of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China
Fudan University
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.
Arms & Interventions
Treatment arm
Patients who received intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention
Intervention: Nicorandil
Placebo arm
Patients who received intravenous placebo before and after reperfusion with primary primary percutaneous coronary intervention
Intervention: Placebo
Outcomes
Primary Outcomes
Major adverse cardiac events
Time Frame: 12 month after primary PCI
cardiac death, myocardial reinfarction, target vessel revascularization, unplanned hospitalization for heart failure
Secondary Outcomes
- Rate fo complete ST-segment resolution(2 hours after primary PCI)
- Unplanned hospitalization for heart failure(12 months after primary PCI)
- Rate of slow re-flow/no-reflow(3 minutes 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)