UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023489
Receipt No. 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 2018/12/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email 3naika-crc@w3.u-ryukyu.ac.jp

Sponsor
Institute Graduate School of Medicine, University of Ryukyus
Department of Cardiovascular Medicine, Nephrology and Neurology
Institute
Department

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
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 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 No longer recruiting
Date of protocol fixation
2015 Year 12 Month 07 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 04 Day
Last modified on
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.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


Contact us.