Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction

Phase 3

• Conditions: Myocardial Infarction
• Interventions: Drug: Nicorandil

• Registration Number: NCT02449070
• Lead Sponsor: Pusan National University Hospital

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-05-15
• Study First Posted: 2015-05-20
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-20
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicorandil	Nicorandil	Receive nicorandil before primary PCI and thereafter for 6 months along with the standard therapy.

Primary Outcome Measures

Name	Time	Method
Infarct size as measured by cardiac MRI	Six months after primary PCI

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of