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A Randomized, Double-blinded, Placebo-controlled, Multi-center Phase 2 Study to Explore the Efficacy and Safety of Subcutaneous Injection EG-Myocin Immediately Before and After PCI in Patients with Acute ST-Elevation Myocardial Infarction (STEMI)

Status Approved

First Submitted Date

2019/09/03
Registered Date

2019/09/09
Last Updated Date

2019/09/06

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004288
Unique Protocol ID	4-2019-0492
Public/Brief Title	A Randomized, Double-blinded, Placebo-controlled, Multi-center Phase 2 Study to Explore the Efficacy and Safety of Subcutaneous Injection EG-Myocin Immediately Before and After PCI in Patients with Acute ST-Elevation Myocardial Infarction (STEMI)
Scientific Title	A Randomized, Double-blinded, Placebo-controlled, Multi-center Phase 2 Study to Explore the Efficacy and Safety of Subcutaneous Injection EG-Myocin Immediately Before and After PCI in Patients with Acute ST-Elevation Myocardial Infarction (STEMI)
Acronym
MFDS Regulated Study	Yes
IND/IDE Protocol	Yes
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	4-2019-0492
Approval Date	2019-07-11
Institutional Review Board Name	Yonsei University Health System, Severance Hospital, Institutional Review Board
Institutional Review Board Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul
Institutional Review Board Telephone	02-2228-0435
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Chul-Min Ahn
Title	Professor
Telephone	+82-2-395-9457
Affiliation	Yonsei University Health System, Severance Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul
Contact Person for Public Queries
Name	Chul-Min Ahn
Title	Professor
Telephone	+82-2-395-9457
Affiliation	Yonsei University Health System, Severance Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul
Contact Person for Updating Information
Name	Hanna An
Title	Assistant manager
Telephone	+82-70-5080-0285
Affiliation	Eyegene
Address	B-910, 401, Yangcheon-ro, Gangseo-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 6
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-09-16 Anticipated
Target Number of Participant	60
Primary Completion Date	2020-11-02 , Anticipated
Study Completion Date	2021-04-30 , Anticipated
Name of Study	Yonsei University Health System, Severance Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-09-16 ,
Recruitment Status by Participating Study Site 2
Name of Study	Chung-Ang Univerisity Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-10-01 ,
Recruitment Status by Participating Study Site 3
Name of Study	Gachon University Gil Medical Center
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-10-01 ,
Recruitment Status by Participating Study Site 4
Name of Study	Koera University Guro Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-10-01 ,
Recruitment Status by Participating Study Site 5
Name of Study	Korea University Anam Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-10-01 ,
Recruitment Status by Participating Study Site 6
Name of Study	Yonsei University, Wonju Severance Christian Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-10-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Eyegene
Organization Type	Pharmaceutical Company
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Eyegene
Organization Type	Pharmaceutical Company

7. Study Summary

Study Summary Information
Lay Summary	EG-Myocin is expected to reduce or prevent myocardial ischemia / reperfusion injury by inducing normal and stable capillaries through perivascular recruitment by acting on abnormal capillaries at the site of myocardial infarction. The aim of this study was to investigate the effects of subcutaneous EG Myocin on myocardial ischemia / reperfusion injury in patients with ST-segment elevation myocardial infarction who underwent percutaneous coronary intervention (PCI) reperfusion therapy.

Study Summary Information

Lay Summary

EG-Myocin is expected to reduce or prevent myocardial ischemia / reperfusion injury by inducing normal and stable capillaries through perivascular recruitment by acting on abnormal capillaries at the site of myocardial infarction.
The aim of this study was to investigate the effects of subcutaneous EG Myocin on myocardial ischemia / reperfusion injury in patients with ST-segment elevation myocardial infarction who underwent percutaneous coronary intervention (PCI) reperfusion therapy.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Phase2
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	1. Investigational Product(EG-Myocin) 2. Placebo(EG-Myocin 위약)
Number of Arms	2
Arm 1	Arm Label Experimental
	Target Number of Participant 30
	Arm Type Experimental
	Arm Description EG-Myocin SC ingection, Once a day, 5 days
Arm 2	Arm Label Placebo Comparator
	Target Number of Participant 30
	Arm Type Placebo comparator
	Arm Description Placebo SC ingection, Once a day, 5 days

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I21.3)Acute transmural myocardial infarction of unspecified site patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI)
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~75Year
	Description - Ability to provide informed consent - Male : 19 ~ 75 years, Female : 50 ~ 75 years - ST-segment elevation myocardial infarction - PPCI - Able to consent for blood draw
Exclusion Criteria	- Left main coronary artery - Cardiac arrest or arrhythmia where CPR or unscheduled circulatory aids have been used during diagnosis - Cardiac shock - uncontrolled hypertension - CABG, coronary artery bypass graft - An arrhythmia patient who has clinically significant - Severe renal disorders - Severe liver disorders - Medical history of malignant carcinoma within past 3 years - Subjects who have hypersensitivity reaction anamnesis for components of Investigational Product. - Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrolment in this trial
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Inhibitory Effect of Investigational Medicinal Product on Myocardial Ischemia / Reperfusion Injury
Timepoint	V4(4 week), V7(12 week)
Secondary Outcome(s) 1
Outcome	Effect of Investigational Medicinal Product on Physiological Status of Myocardial Infarction
Timepoint	V4(4 week), V7(12 week)

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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