Impact of Intravenous Administration of Nicorandil As Adjuncts to Reperfusion Treatment for Acute ST Segment Elevation Myocardial Infarction: a Multi-center Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Fudan University
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- Major adverse cardiac events
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
Placebo arm
Patients who received intravenous placebo before and after reperfusion with primary primary percutaneous coronary intervention
Intervention: Placebo (Drug)
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)
Investigators
Ge Junbo
Director, Dept. of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China
Fudan University