臨床研究等提出・公開システム

Date of registration	Jan. 30, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221705

Scientific Title	Phase II clinical study of TY-51924 in patients with acute myocardial infarction - Proof of concept study -
Public Title	Proof of concept study of TY-51924 in patients with acute myocardial infarction

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	TOA EIYO LTD.
	Address	ct_info@toaeiyo.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		100
Study Type		Interventional
Study Design	Study Design	Multicenter, randomized, double-blind, placebo-controlled, parallel-assignment
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	1) Admission to hospital within 6 hrs of the onset of symptoms 2) Chest pain lasting for >= 30 min 3) ST-segment elevation of >= 0.2 mV in 2 or more contiguous precordial leads (V1-V4) on standard 12-lead electrocardiogram 4) TIMI flow grade 0/1 in left anterior descending artery (LAD) on diagnostic coronary angiography (CAG) 5) Written informed consent
	Exclusion Criteria	1) Prior documented old myocardial infarction (MI) or a clinical history of definite MI 2) Left main trunk (LMT) stenosis >50% 3) Total occlusion of left circumflex artery (LCX) or right coronary artery (RCA) 4) Left bundle-branch block 5) Suspected acute aortic dissection 6) Cardiac arrest or cardiogenic shock 7) Thrombolytic therapy or coronary artery bypass grafting (CABG) 8) Hepatic and/or renal dysfunction 9) History of allergy or drug hypersensitivity 10) Pregnancy or nursing mothers or childbearing women
	Minimum Age	20age old over
	Maximum Age	79age old under
	Gender	Both
Health Condition or Problem Studied		Acute myocardial infarction
Intervention(s)		investigational material(s) Generic name etc : TY-51924 INN of investigational material : Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investigational material : Intravenous injection control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Intravenous injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		1) Myocardial salvage index at 3-5 days after percutaneous coronary intervention (PCI) 2) Incidence of adverse events and side effects for 7 days after PCI
Secondary Outcome		1) Events for 3 months after PCI 2) Incidence of adverse events and side effects for 3 months after PCI 3) MI size, left ventricular function and 12-lead electrocardiogram

Primary Sponsor	TOA EIYO LTD.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-121747
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Oct. 30, 2013	Detail	Changes
5	Oct. 30, 2013	Detail	Changes
4	Aug. 10, 2012	Detail	Changes
3	Aug. 10, 2012	Detail	Changes
2	Jan. 30, 2012	Detail	Changes
1	Jan. 30, 2012	Detail

List of change history