UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of Response to Thienopyridine in Japanese Population (ART-JP)
Acronym	ART-JP
Scientific Title	Assessment of Response to Thienopyridine in Japanese Population (ART-JP)
Scientific Title:Acronym	ART-JP
Region	Japan

Condition
Condition	coronary artery disease (CAD)
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Assessment of relationships between platelet function and efficacy or adverse effect in patients with CAD receiving PCI and newly administered thienopyridine
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	cardiac death, fatal stroke, non-fatal myocardial infarction, stent thrombosis
Key secondary outcomes	repeat PCI, non cardiovasular death, non-fatal stroke, non-fatal cerebral hemorrhage, bleeding (STEEPLE major or minor), change in bio-marker

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients receiving PCI and newly administered thienopyridine
Key exclusion criteria	1) patients without consent 2) AST > or = 3 x upper limit or ALT > or = 3 x upper 3) Hb < 10 g/dl or platelet < 100k 4) drug allergy to thienopyridine 5) patients with malignancy under treatment or planning to start treatment within one year 6) primary physician thinks it is inappropriate to enroll the patient
Target sample size	300

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Mitsuru Murata
Organization	Keio University School of Medicine
Division name	Department of Laboratory Medicine
Zip code
Address	35 Shinano-machi Shinjuku-ku Tokyo 160-8582, Japan
TEL	81-3-3353-1211
Email

Public contact
1st name of contact person	1st name Middle name Last name Kenji Yokoyama
Organization	Keio University, School of Meidicine
Division name	Division of Hematology, Department of Medicine
Zip code
Address	35 Shinano-machi Shinjuku-ku Tokyo 160-8582, Japan
TEL	81-3-3353-1211
Homepage URL
Email	keyokoya@sc.itc.keio.ac.jp

Sponsor
Institute	Keio University, School of Medicine, Research Park 5S9
Institute
Department

Funding Source
Organization	DAIICHI SANKYO COMPANY LIMITED
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2011 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 06 Month 01 Day
Date of IRB	2010 Year 06 Month 01 Day
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date	2014 Year 03 Month 31 Day
Date of closure to data entry	2014 Year 03 Month 31 Day
Date trial data considered complete	2014 Year 03 Month 31 Day
Date analysis concluded	2014 Year 03 Month 31 Day

Other
Other related information	primary endpoint cardiac death, fatal stroke, non-fatal myocardial infarction, stent thrombosis secondary endpoint repeat PCI, non cardiovasular death, non-fatal stroke, non-fatal cerebral hemorrhage, bleeding (STEEPLE major or minor), change in bio-marker

Management information
Registered date	2011 Year 09 Month 12 Day
Last modified on	2019 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007513