UMIN-CTR Clinical Trial

Basic information
Public title	Impact of Cytochrome P450 2C19*2 Polymorphism on Intra-Stent Thrombus After drug eluting stent Implantation Receiving Clopidogrel.
Acronym	Impact of Cytochrome P450 2C19*2 Polymorphism on Intra-Stent Thrombus After drug eluting stent Implantation.
Scientific Title	Impact of Cytochrome P450 2C19*2 Polymorphism on Intra-Stent Thrombus After drug eluting stent Implantation Receiving Clopidogrel.
Scientific Title:Acronym	Impact of Cytochrome P450 2C19*2 Polymorphism on Intra-Stent Thrombus After drug eluting stent Implantation.
Region	Japan

Condition
Condition	Stable coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To solve the relationship between intra-stent thrombus and antiplatelet function and cardiovasculae event in CYP2C19 carriers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	frequency of intra stent thrombus in CYP2C19 carriers.
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)coronary artery disease who received clopidogrel 75mg per day and aspirin 100mg pre day. 2)The patient who is going to undergo percutaneous coronary intervention with DES. 3)The patient who is eligible to VerifyNow measurement. 4)The patient who agree with a Document consent after informed consent.
Key exclusion criteria	1)The patient who has a plan to receive surgical procedure. 2)The patient who received anticoagulant agent, thrombolytic drug, antiplatelet drug other than aspirin or clopidogrel. 3)There is contraindication of aspirin or clopidogrel. 4)The patient who do not agree with this trial. 5)inappropriate patient.
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Toshiro Shinke
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	078-382-5111
Email	shinke@med.kobe-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Natsuko Tahara
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	81-78-382-5846
Homepage URL
Email	macadamia_chocolate@icloud.com

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Daiichi Sankyo Company, Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 30 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	2011 Year 04 Month 01 Day
Date of IRB	2011 Year 05 Month 15 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 05 Month 31 Day
Date trial data considered complete	2016 Year 05 Month 31 Day
Date analysis concluded	2016 Year 06 Month 30 Day

Other
Other related information	.

Management information
Registered date	2012 Year 05 Month 30 Day
Last modified on	2019 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009446