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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02449070
• Other study ID #: D-1407-011-030
• Status: Recruiting
• Phase: Phase 3
• First received: May 13, 2015
• Last updated: September 18, 2017
• Start date: May 2015
• Est. completion date: October 2018

Study information

• Verified date: September 2017
• Source: Pusan National University Hospital
• Contact: Jun-Hyok Oh, MD
• Phone: 82-51-240-7794
• Email: jhoh724[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Nicorandil
4 mg iv after randomization, 2 mg ic just before ballooning, 2 mg ic just before stenting

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Pusan

Sponsors (2)

Lead Sponsor	Collaborator
Pusan National University Hospital	JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size as measured by cardiac MRI		Six months after primary PCI
Secondary	LVEF(%) as measured by cardiac MRI		Five days and 6 months after primary PCI
Secondary	MVO as measured by cardiac MRI		Five days after primary PCI
Secondary	ST-segment resolution		One hour after primary PCI
Secondary	MACE (Death, Spontaneous MI, Stroke)		up to 6 months