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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017624
Receipt No. 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

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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
Email 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
Email r0742sn@jichi.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine, Jichi Medical University 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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018136

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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