臨床研究等提出・公開システム

Date of registration	July. 12, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221511

Scientific Title	CS-747S PhaseIII trial -Double-blinded study for evaluation of efficacy and safety of CS-747S in reference to clopidogrel bisulfate in subject with coronary arterial disease who are to undergo elective percutaneous coronary intervention-
Public Title	CS-747S PhaseIII trial (elective PCI)

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		600
Study Type		Interventional
Study Design	Study Design	Multi-center, double-blind, randomized outcomes study in 600 Japanese patients with stable CAD undergoing elective PCI.
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	-Subjects aged 20 or above when written informed consent were signed by the subjects. -CAD patients with coronary artery stenosis identified by coronary angiography or CT scan, and scheduled for elective PCI.
	Exclusion Criteria	-High bleeding risk -Subjects with ACS -Liver and/or kidney function impairment
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		CAD patients who are to undergo elective PCI
Intervention(s)		investigational material(s) Generic name etc : Prasugrel Hydrochloride 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 Six months MACE and 95% confidence intervals are to be calculated, and the cumulative event rate are estimated by Kaplan-Meier method.
Secondary Outcome		The rate of non-CABG bleeding events. The incidence of bleeding events and their 95% confidence intervals are to be calculated.

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-111550
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

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

List of change history