UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006336 |
|---|---|
| Receipt number | R000007513 |
| Scientific Title | Assessment of Response to Thienopyridine in Japanese Population (ART-JP) |
| Date of disclosure of the study information | 2011/09/13 |
| Last modified on | 2019/03/26 15:43:33 |
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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
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
Public contact
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
keyokoya@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio University, School of Medicine, Research Park 5S9
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007513
