UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023489 |
|---|---|
| Receipt number | R000027055 |
| Scientific Title | Comparative evaluation of thienopyridines on platelet aggregation in patients with ischemic heart disease in multi-centers in Okinawa |
| Date of disclosure of the study information | 2016/08/31 |
| Last modified on | 2021/01/28 16:56:07 |
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Basic information
Public title
Comparative evaluation of thienopyridines on platelet
aggregation in patients with ischemic heart disease in multi-centers in Okinawa
Acronym
CHIMU Okinawa Study
Scientific Title
Comparative evaluation of thienopyridines on platelet
aggregation in patients with ischemic heart disease in multi-centers in Okinawa
Scientific Title:Acronym
CHIMU Okinawa Study
Region
| Japan |
Condition
Condition
coronary heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to compare with the platelet aggregation ability by clopidogrel maintenance dose remedy and the platelet aggregation ability after the change in prasugrel and to evaluate the safety of switching from clopidogrel to prasugrel and participation of CYP2C19.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Platelet aggregation ability (PRU in VerifyNow) at the time of clopidogrel remedy and the prasugrel remedy
Key secondary outcomes
Complications including a cardiovascular event and the bleeding until one year later.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
continuation group of the maintenance dose by the clopidogrel(75mg/day)
Interventions/Control_2
It is change group from clopidogrel of the maintenance dose in prasugrel(3.75mg./day) of the maintenance dose
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The chronic coronary disease patient who is taking clopidogrel for more than one month.
Key exclusion criteria
1)Dialysis
2)Dangerously ill liver disease patient
3)Malignant tumor of the activity
4)The patient that art of planned coronary revasculalization is not completed
5)PCI enforcement patients within 7 days
6)Dangerously ill heart failure patient(LVEFless than 30%. NYHA IV)
7)More than less than 50,000 number of the platelets /micro l or 500,000 /micro l, it is less than 30% of hematocrit or more than 50%
8)Bleeding patient
9)Patients who need treatment with anticoagulant
10)The patient who is participating in other clinical trials
11)Pregnant patient
12)the patient who judged that the medical attendant was inappropriate
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Iwabuchi |
Organization
Graduate School of Medicine, University of Ryukyus
Division name
Department of Cardiovascular Medicine, Nephrology and Neurology
Zip code
Address
207 Uehara, Nishihara-cho, Okinawa, Japan
TEL
098-895-1150
msiwabuchi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Iwabuchi |
Organization
Graduate School of Medicine, University of Ryukyus
Division name
Department of Cardiovascular Medicine, Nephrology and Neurology
Zip code
Address
207 Uehara, Nishihara-cho, Okinawa, Japan
TEL
098-895-1150
Homepage URL
3naika-crc@w3.u-ryukyu.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, University of Ryukyus
Department of Cardiovascular Medicine, Nephrology and Neurology
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO co.,LTD.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
琉球大学附属病院（沖縄県）、沖縄県立中部病院（沖縄県）、浦添総合病院（沖縄県）、那覇市立病院（沖縄県）、大浜第一病院（沖縄県）、豊見城中央病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 31 | 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
| 2015 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 03 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 16 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 04 | Day |
Last modified on
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027055
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/12/27 | 【5.0版】研究計画書CHIMU Okinawa Study.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
