Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction : A Randomized Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Nicorandil
- Conditions
- Myocardial Infarction
- Sponsor
- Pusan National University Hospital
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Infarct size as measured by cardiac MRI
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to determine whether nicorandil reduce cardiac infarct size in patient with ST-segment elevation acute myocardial infarction.
Detailed Description
Study objective : To investiage whether nicorandil treatment reduce infarct size measured by cardiac MRI at 6 months after primary PCI Allocation : 1. Nicorandil arm : Recieve nicorandil 4 mg i.v. before undergoing PCI, additionall 2mg i.c. just before 1st ballooning, additionall 2mg i.c. just before stenting, After successful PCI, 10 mg/day (or 5 mg/day) p.o. for 6 months. 2. Control arm : Recieve standard treatment including PCI, but avoid nicoranil and adenosine. Follow-up and Measurement : Cardiac MRI scans are scheduled at 5 days and 6 months after primary PCI. Clinically followed upto 6 months after parimary PCI.
Investigators
Jun-Hyok OH
Assistant professor
Pusan National University Hospital
Eligibility Criteria
Inclusion Criteria
- •STEMI patients presenting within 12 hours after symptom onset
- •Undergoing primary PCI
Exclusion Criteria
- •Previous myocardial infarction
- •Atrial fibrillation
- •RV infarction
- •Cardiogenic shock
- •Serum creatinine \>2.0 mg/dL
- •Narrow angle glaucoma
- •Taking PDE-5 inhibitors
Arms & Interventions
Nicorandil
Receive nicorandil before primary PCI and thereafter for 6 months along with the standard therapy.
Intervention: Nicorandil
Outcomes
Primary Outcomes
Infarct size as measured by cardiac MRI
Time Frame: Six months after primary PCI
Secondary Outcomes
- ST-segment resolution(One hour after primary PCI)
- MVO as measured by cardiac MRI(Five days after primary PCI)
- LVEF(%) as measured by cardiac MRI(Five days and 6 months after primary PCI)
- MACE (Death, Spontaneous MI, Stroke)(up to 6 months)