NCT02449070

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

3.4 years

First QC Date

May 13, 2015

Last Update Submit

September 18, 2017

Conditions

Myocardial Infarction

Keywords

NicorandilCardiac MRI

Outcome Measures

Primary Outcomes (1)

  • Infarct size as measured by cardiac MRI

    Six months after primary PCI

Secondary Outcomes (4)

  • 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

    One hour after primary PCI

  • MACE (Death, Spontaneous MI, Stroke)

    up to 6 months

Study Arms (2)

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

NicorandilDRUG

4 mg iv after randomization, 2 mg ic just before ballooning, 2 mg ic just before stenting

Also known as: Nicrodandil
Nicorandil

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • STEMI patients presenting within 12 hours after symptom onset
  • Undergoing primary PCI

You may not qualify if:

  • Previous myocardial infarction
  • Atrial fibrillation
  • RV infarction
  • Cardiogenic shock
  • Serum creatinine \>2.0 mg/dL
  • Narrow angle glaucoma
  • Taking PDE-5 inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Hospital

Pusan, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Nicorandil

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

NitratesOrganic ChemicalsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jun-Hyok Oh, MD

    Pusan National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun-Hyok Oh, MD

CONTACT

82-51-240-7794jhoh724@hanmail.net

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 20, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

September 20, 2017

Record last verified: 2017-09

Locations

KR(1)