UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008058 |
|---|---|
| Receipt number | 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 09:15:11 |
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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
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
macadamia_chocolate@icloud.com
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009446
