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

Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction : A Randomized Clinical Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02449070

Enrollment

Registered

2015-05-20

Start date

2015-05-31

Completion date

2018-10-31

Last updated

2017-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Nicorandil, Cardiac MRI

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.

Interventions

DRUGNicorandil

4 mg iv after randomization, 2 mg ic just before ballooning, 2 mg ic just before stenting

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Infarct size as measured by cardiac MRI	Six months after primary PCI

Secondary

Measure	Time frame
LVEF(%) as measured by cardiac MRI	Five days and 6 months after primary PCI
MVO as measured by cardiac MRI	Five days after primary PCI
ST-segment resolution	One hour after primary PCI
MACE (Death, Spontaneous MI, Stroke)	up to 6 months

Countries

South Korea

Contacts

Primary ContactJun-Hyok Oh, MD

jhoh724@hanmail.net82-51-240-7794

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026