UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008058
Receipt No. R000009446
Scientific Title Impact of Cytochrome P450 2C19*2 Polymorphism on Intra-Stent Thrombus After drug eluting stent Implantation Receiving Clopidogrel.
Date of disclosure of the study information 2012/05/30
Last modified on 2019/05/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.