UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Mie Study of Clopidogrel Low Responder in Atherothrombotic Disease Patients with/without Diabetes
Title of the study (Brief title)	Mie Study of Clopidogrel Low Responder in Atherothrombotic Disease Patients with/without Diabetes (McLORDD Study)
Region	Japan

Condition
Condition	Atherothrombotic disease
Classification by specialty	Cardiology Neurology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To develop new monitoring techniques and to evaluate the frequency of poor-responder for clopidogrel for Japanese atherothrombotic patients
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To develop the monitoring techniques of poor-responder for clopidgrel
Key secondary outcomes	Relationship of SNIP of CYP2C19 Relationship of DM

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	1) Stable atherothrombotic patients (coronary disease and cerebral infarction without embolization from the heart) before taking clopidgrel or taking clopidgrel more than 14days or taking cilostazol. 2) Patients have the following laboratory data Ht 33-52% Platelet 119000-50200/uL Triglyceride 41-824 mg/dL T-Cholesterol 98-316 mg/dL Fibrinogen 171-599 mg/dL 3) Written informed consent from the patient
Key exclusion criteria	1) Patients before operation 2) Cerebral infraction without embolization from the heart 3) Taking following drugs, warfarin, thrombolytic agents, heparin, etc. anti-platelet drugs except aspirin, clopidogrel or cilostazol (e.g., sarpogrelate, diryridamole, EPA, etc.) 4) Not eligible determind by the responding physician
Target sample size	250

Research contact person
Name of lead principal investigator	Masakatsu Nishikawa
Organization	Mie university faculty of medicine
Division name	Institute of human research promotion and drug development
Address	2-174, Edobashi, Tsu, MIE
TEL	059-231-5431
Email	nisikawa@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Yuki Nishimura
Organization	Mie university hospital
Division name	Clinical research support center
Address	2-174, Edobashi, Tsu, MIE
TEL	059-231-5278
Homepage URL
Email	ynishimura@clin.medic.mie-u.ac.jp

Sponsor
Institute	McLORDD, Coordinating Office
Institute
Department

Funding Source
Organization	Daiichi Sankyou
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	三重大学医学部附属病院(三重県)、松阪中央総合病院(三重県)、済生会松阪総合病院(三重県)、松阪市民病院(三重県)、三重県立総合病院(三重県)、三重中央医療センター(三重県)、永井病院(三重県)、遠山病院(三重県)、鈴鹿回生病院(三重県)、市立四日市病院(三重県)

Other administrative information
Date of disclosure of the study information	2008 Year 12 Month 15 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2008 Year 10 Month 31 Day
Anticipated trial start date	2008 Year 11 Month 01 Day
Last follow-up date	2014 Year 04 Month 13 Day
Date of closure to data entry	2014 Year 04 Month 30 Day
Date trial data considered complete	2014 Year 05 Month 30 Day
Date analysis concluded	2014 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/circj/77/6/77_CJ-12-1095/_article
Results	CYP2C19 loss-of-function genotype is associated with more frequent high platelet reactivity, as assessed by ADP-specific platelet function tests, in Japanese patients.
Other related information	To develop the monitoring techniques of poor-responder for clopidogrel Relationship of SNIP of CYP2C19 Relationship of DM

Management information
Registered date	2008 Year 12 Month 15 Day
Last modified on	2016 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001892