UMIN-CTR Clinical Trial

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
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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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