Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction
NCT ID: NCT02449070
Last Updated: 2017-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
86 participants
INTERVENTIONAL
2015-05-31
2018-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nicorandil
Receive nicorandil before primary PCI and thereafter for 6 months along with the standard therapy.
Nicorandil
4 mg iv after randomization, 2 mg ic just before ballooning, 2 mg ic just before stenting
Control
Receive primary PCI and the standard therapy.
No interventions assigned to this group
Interventions
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Nicorandil
4 mg iv after randomization, 2 mg ic just before ballooning, 2 mg ic just before stenting
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing primary PCI
Exclusion Criteria
* Atrial fibrillation
* RV infarction
* Cardiogenic shock
* Serum creatinine \>2.0 mg/dL
* Narrow angle glaucoma
* Taking PDE-5 inhibitors
20 Years
ALL
No
Sponsors
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JW Pharmaceutical
INDUSTRY
Pusan National University Hospital
OTHER
Responsible Party
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Jun-Hyok OH
Assistant professor
Principal Investigators
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Jun-Hyok Oh, MD
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Hospital
Locations
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Pusan National University Hospital
Pusan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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D-1407-011-030
Identifier Type: -
Identifier Source: org_study_id