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

September 18, 2017 updated by: Jun-Hyok OH, Pusan National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicorandil
Receive nicorandil before primary PCI and thereafter for 6 months along with the standard therapy.
Drug: Nicorandil
4 mg iv after randomization, 2 mg ic just before ballooning, 2 mg ic just before stenting
Other Names:
  • Nicrodandil
No Intervention: Control
Receive primary PCI and the standard therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infarct size as measured by cardiac MRI
Time Frame: Six months after primary PCI
Six months after primary PCI

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Collaborators

JW Pharmaceutical

Investigators

  • Principal Investigator: Jun-Hyok Oh, MD, Pusan National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

May 15, 2015

First Posted (Estimate)

May 20, 2015

Study Record Updates

Last Update Posted (Actual)

September 20, 2017

Last Update Submitted That Met QC Criteria

September 18, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-1407-011-030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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