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

Pusan National University

Status and phase: Unknown; Phase 3

Conditions: Myocardial Infarction

Treatments: Drug: Nicorandil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02449070

D-1407-011-030

Details and patient eligibility

About

The purpose of this study is to determine whether nicorandil reduce cardiac infarct size in patient with ST-segment elevation acute myocardial infarction.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Nicorandil

Experimental group

Description:

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

Treatment:

Drug: Nicorandil

Control

No Intervention group

Description:

Receive primary PCI and the standard therapy.