UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041125 |
|---|---|
| Receipt number | R000046959 |
| Scientific Title | A pilot study investigating change of platelet function during interruption of P2Y12 inhibitor |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2020/07/16 15:58:21 |
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Basic information
Public title
A pilot study investigating change of platelet function during interruption of P2Y12 inhibitor
Acronym
A pilot study investigating change of platelet function during interruption of P2Y12 inhibitor
Scientific Title
A pilot study investigating change of platelet function during interruption of P2Y12 inhibitor
Scientific Title:Acronym
A pilot study investigating change of platelet function during interruption of P2Y12 inhibitor
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the change of P2Y12 reaction unit (PRU) during interruption of P2Y12 inhibitor.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PRU change among P2Y12 inhibitors (prasugrel, clopidogrel, ticagrelor)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
interruption of prasugrel
Interventions/Control_2
interruption of clopidogrel
Interventions/Control_3
interruption of ticagrelor
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are planned to interrupt a P2Y12 inhibitor
Key exclusion criteria
Patients who are adjudicated ineligible to the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Kobayashi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of cardiovascular medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
yuiryosuke@msn.com
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Sato |
Organization
Chiba University Graduate School of Medicine
Division name
Department of cardiovascular medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
t-satoh@outlook.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Graduate School of Medicine
Address
1-8-1 Inohana, Chuo-ku, Chiba
Tel
043-222-7171
inohana-rinri@chiba-u.jp
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2020 | Year | 07 | Month | 16 | Day |
Last modified on
| 2020 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046959
