UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001574 |
|---|---|
| Receipt number | 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 13:54:40 |
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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
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
ynishimura@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
McLORDD, Coordinating Office
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001892
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
