Effects of Nicorandil on Cardiac Infarct Size in Patients... | NCT02449070

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

NCT02449070

Sponsor

Pusan National University Hospital

Status

Unknown status

Last Update Posted

Sep 20, 2017Actual

Enrollment

86Estimated

Phase

Phase 3

Conditions

Myocardial Infarction

Interventions

Nicorandil

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Oct 2018Estimated

Completion Date

Oct 2018Estimated

First Submitted Date

May 13, 2015

First Submission Date that Met QC Criteria

May 15, 2015

First Posted Date

May 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2017

Last Update Posted Date

Sep 20, 2017Actual

Name	Class
JW Pharmaceutical	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nicorandil	Experimental	Receive nicorandil before primary PCI and thereafter for 6 months along with the standard therapy.	Drug: Nicorandil
Control	No Intervention	Receive primary PCI and the standard therapy.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nicorandil	Drug	4 mg iv after randomization, 2 mg ic just before ballooning, 2 mg ic just before stenting	Nicorandil

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun-Hyok Oh, MD	Contact	82-51-240-7794		jhoh724@hanmail.net

Overall Officials

Name	Affiliation	Role
Jun-Hyok Oh, MD	Pusan National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pusan National University Hospital	Recruiting	Pusan			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020108	Nicorandil

Ancestor Terms

ID	Term
D009566	Nitrates
D009930	Organic Chemicals
D009536	Niacinamide
D009539	Nicotinic Acids

Browse Leaves

Not provided

Browse Branches

Not provided