臨床研究等提出・公開システム

Date of registration	Nov. 10, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221302

Scientific Title	CS-747S PhaseIII trial -Double-blinded comparative study for evaluation of efficacy and safety of CS-747S versus clopidogrel bisulfate in subject with acute coronary syndromes who are to undergo percutaneous coronary intervention-
Public Title	CS-747S PhaseIII trial

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	DAIICHI SANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		1200
Study Type		Interventional
Study Design	Study Design	Multi-center, randomized, double-blind, double-dummy, parallel group study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	-Are 20 or above when informed consent is written. -Have recent acute coronary syndrome defined as a recent history of ischemic symptoms at rest associated with ECG changes consistent with ischemia and/or elevated cardiac enzymes, and are scheduled for PCI.
	Exclusion Criteria	-High bleeding risk -Subjects who have severe complication to be treated (e.g. refractory arrhythmia, malignancy) -hepatic disease or renal disorder
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Subject with acute coronary syndromes who are to undergo percutaneous coronary intervention (PCI)
Intervention(s)		investigational material(s) Generic name etc : CS-747S INN of investigational material : prasugrel Therapeutic category code : 339 Other agents relating to blood and body fluides Dosage and Administration for Investigational material : Loading dose: 4 tablets, Maintenance dose: 1 tablets p.o. qd control material(s) Generic name etc : Clopidogrel bisulfate INN of investigational material : clopidogrel Therapeutic category code : 339 Other agents relating to blood and body fluides Dosage and Administration for Investigational material : Loading dose: 4 tablets, Maintenance dose: 1 tablets p.o. qd
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Rate of MACE Calculating hazard ratio from event rate after administration of study drug.
Secondary Outcome		The rate of bleeding event which is unrelated to CABG Evaluating the percentage of bleeding event.

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor	Ube Industries, Ltd.

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-101339
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
15	Dec. 17, 2018	(this page)	Changes
14	June. 02, 2015	Detail	Changes
13	June. 02, 2015	Detail	Changes
12	June. 02, 2015	Detail	Changes
11	June. 02, 2015	Detail	Changes
10	Mar. 19, 2013	Detail	Changes
9	Mar. 19, 2013	Detail	Changes
8	Feb. 23, 2012	Detail	Changes
7	Feb. 23, 2012	Detail	Changes
6	July. 14, 2011	Detail	Changes
5	July. 14, 2011	Detail	Changes
4	Jan. 07, 2011	Detail	Changes
3	Jan. 07, 2011	Detail	Changes
2	Nov. 10, 2010	Detail	Changes
1	Nov. 10, 2010	Detail

List of change history