Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction
Primary Purpose
Myocardial Infarction
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nicorandil
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Nicorandil, Cardiac MRI
Eligibility Criteria
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
Sites / Locations
- Pusan National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nicorandil
Control
Arm Description
Receive nicorandil before primary PCI and thereafter for 6 months along with the standard therapy.
Receive primary PCI and the standard therapy.
Outcomes
Primary Outcome Measures
Infarct size as measured by cardiac MRI
Secondary Outcome Measures
LVEF(%) as measured by cardiac MRI
MVO as measured by cardiac MRI
ST-segment resolution
MACE (Death, Spontaneous MI, Stroke)
Full Information
NCT ID
NCT02449070
First Posted
May 13, 2015
Last Updated
September 18, 2017
Sponsor
Pusan National University Hospital
Collaborators
JW Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT02449070
Brief Title
Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction
Official Title
Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction : A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Hospital
Collaborators
JW Pharmaceutical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 :
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Nicorandil, Cardiac MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nicorandil
Arm Type
Experimental
Arm Description
Receive nicorandil before primary PCI and thereafter for 6 months along with the standard therapy.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Receive primary PCI and the standard therapy.
Intervention Type
Drug
Intervention Name(s)
Nicorandil
Other Intervention Name(s)
Nicrodandil
Intervention Description
4 mg iv after randomization, 2 mg ic just before ballooning, 2 mg ic just before stenting
Primary Outcome Measure Information:
Title
Infarct size as measured by cardiac MRI
Time Frame
Six months after primary PCI
Secondary Outcome Measure Information:
Title
LVEF(%) as measured by cardiac MRI
Time Frame
Five days and 6 months after primary PCI
Title
MVO as measured by cardiac MRI
Time Frame
Five days after primary PCI
Title
ST-segment resolution
Time Frame
One hour after primary PCI
Title
MACE (Death, Spontaneous MI, Stroke)
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun-Hyok Oh, MD
Phone
82-51-240-7794
Email
jhoh724@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun-Hyok Oh, MD
Organizational Affiliation
Pusan National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun-Hyok Oh, MD
Email
jhoh724@hanmail.net
12. IPD Sharing Statement
Learn more about this trial
Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction
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