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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001574
Receipt No. R000001892
Scientific Title Mie Study of Clopidogrel Low Responder in Atherothrombotic Disease Patients with/without Diabetes
Date of disclosure of the study information 2008/12/15
Last modified on 2016/08/23

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Basic information
Public title Mie Study of Clopidogrel Low Responder in Atherothrombotic Disease Patients with/without Diabetes
Acronym Mie Study of Clopidogrel Low Responder in Atherothrombotic Disease Patients with/without Diabetes (McLORDD Study)
Scientific Title Mie Study of Clopidogrel Low Responder in Atherothrombotic Disease Patients with/without Diabetes
Scientific Title:Acronym 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
1st name
Middle name
Last name Masakatsu Nishikawa
Organization Mie university faculty of medicine
Division name Institute of human research promotion and drug development
Zip code
Address 2-174, Edobashi, Tsu, MIE
TEL 059-231-5431
Email nisikawa@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Nishimura
Organization Mie university hospital
Division name Clinical research support center
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/circj/77/6/77_CJ-12-1095/_article
Number of participants that the trial has enrolled
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.
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 Main results already published
Date of protocol fixation
2008 Year 10 Month 31 Day
Date of IRB
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

Other
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

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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