UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014914 |
|---|---|
| Receipt number | R000017350 |
| Scientific Title | Impact of CYP genetic polymorphism on clinical events after percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) : An ancillary study of the Japanese CTO PCI Expert Registry |
| Date of disclosure of the study information | 2014/08/21 |
| Last modified on | 2015/09/04 10:10:34 |
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Basic information
Public title
Impact of CYP genetic polymorphism on clinical events after percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) : An ancillary study of the Japanese CTO PCI Expert Registry
Acronym
CYP genetic polymorphism and clinical events in the Japanese CTO PCI Expert Registry
Scientific Title
Impact of CYP genetic polymorphism on clinical events after percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) : An ancillary study of the Japanese CTO PCI Expert Registry
Scientific Title:Acronym
CYP genetic polymorphism and clinical events in the Japanese CTO PCI Expert Registry
Region
| Japan |
Condition
Condition
Chronic total occlusion
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify an association between CYP2C19 genetic polymorphism and acute/chronic stent reocclusion in patients who received Clopidogrel after PCI for CTO
Basic objectives2
Others
Basic objectives -Others
Assessment of pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major adverse cardiocerebral events (MACCE) and reocclusion during the first year
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.Patients enrolled in the Japanese CTO PCI Expert Registry from July 2013 to June 2015 who are able to be followed up for five years
2.Patients after successful stent implantation without complications
3.Patients taking clopidogrel
4.Patients who give written informed consent for the analysis of CYP2C19 genetic polymorphism
5.Patients who are able to undergo follow-up coronary angiography or multislice computed tomography after one year
Key exclusion criteria
Patients who are ineligible for the Japanese CTO PCI Expert Registry
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Katoh |
Organization
Kusatsu Heart Center
Division name
Adviser
Zip code
Address
407-1 Komaisawa-cho, Kusatsu, Shiga, Japan
TEL
077-568-5333
okatoh653@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Oka |
Organization
Public interest incorporated foundation Ohara HealthCare Foundation
Division name
Kurashiki Clinical Research Institute
Zip code
Address
1-1-1 Miya, Kurashiki city, Okayama, Japan
TEL
086-486-3317
Homepage URL
http://www.ctopci.com
cto.e.registry@gmail.com
Sponsor or person
Institute
Japanese board of Chronic Total Occlusion Interventional specialist
(General Incorporated Association)
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
| 2014 | Year | 08 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2014 | Year | 08 | Month | 21 | Day |
Last modified on
| 2015 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017350
