UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017624 |
|---|---|
| Receipt number | R000018136 |
| Scientific Title | Platelet response to prasugrel and clopidogrel loadinig doses in elective PCI patients |
| Date of disclosure of the study information | 2015/05/21 |
| Last modified on | 2018/03/07 10:09:05 |
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Basic information
Public title
Platelet response to prasugrel and clopidogrel loadinig doses in elective PCI patients
Acronym
Comparison of platelet responses to different thienopyridines
Scientific Title
Platelet response to prasugrel and clopidogrel loadinig doses in elective PCI patients
Scientific Title:Acronym
Comparison of platelet responses to different thienopyridines
Region
| Japan |
Condition
Condition
Elective PCI
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To determine appropriate administration method of thienopyridine in Japanese patients undergoing elective percutaneous coronary intervention by comparing platelet function.
Basic objectives2
Others
Basic objectives -Others
To identify independent variables to affect platelet responses to thieonopyridines.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Responses of platelets to the treatment with prasugrel and clopidogrel.
Key secondary outcomes
To investigate the frequency of bleeding complication such as gross hematuria,subcutaneous bleeding,hemoglobin change after percutaneous coronary intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
prasugrel group
Interventions/Control_2
clopidogrel group
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)Stable angina pectoris patient scheduled for elective coronary artery stenting.
(2)Patient who takes aspirin.
(3)One of the tests (cardiac computed tomography, stress technetium myocardial scintigraphy, exercise tredmil test) is positive.
(4)Patient who give informed consent to this study.
Key exclusion criteria
(1)Concomitant use of other antiplatelet drugs other than aspirin.
(2)Participation in other clinical trial.
(3)Platelet counts of <10x107/ml or >40x107/ml
(4)Malignant disease or autoimmune disease.
(5)Judgment by physician that a patient is inappropriate to enroll the study.
(6)Patient who have communication difficulty.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuomi Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285-44-2111
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Niijima |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285-44-2111
Homepage URL
r0742sn@jichi.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Jichi Medical University 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
| 2015 | Year | 05 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 19 | Day |
Last modified on
| 2018 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018136
