UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028077 |
|---|---|
| Receipt number | R000032138 |
| Scientific Title | Intervention study of assessing platelet aggregation about patients receiving Ticagrelor with old myocardial infarction |
| Date of disclosure of the study information | 2017/07/05 |
| Last modified on | 2019/01/21 16:17:53 |
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Basic information
Public title
Intervention study of assessing platelet aggregation about patients receiving Ticagrelor with old myocardial infarction
Acronym
Assessment of platelet aggregation about OMI patients receiving Ticagrelor
Scientific Title
Intervention study of assessing platelet aggregation about patients receiving Ticagrelor with old myocardial infarction
Scientific Title:Acronym
Assessment of platelet aggregation about OMI patients receiving Ticagrelor
Region
| Japan |
Condition
Condition
Old myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the platelet aggregation of old myocardial infarction patients receiving meintenance dose Ticagrelor with Prasugrel using VN-P2Y12
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
To compare the average value of P2Y12 reaction units (PRU) after administration of Ticagrelor for 14 days with Prasugrel
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of Ticagrelor
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Old myocardial infarction patients who had emergent PCI 3 months ago.
Key exclusion criteria
Patients with contraindications against Tiacgrelor
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosio Kobayashi |
Organization
Chiba university hospital
Division name
Cardiology
Zip code
Address
Inoohana 1-8-1, chuoku, chiba
TEL
043-222-7171
kazuyatateishi0926@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Tateishi |
Organization
Chiba university hospital
Division name
Cardiology
Zip code
Address
Inohana 1-8-1, chuoku, chiba
TEL
043-222-7171
Homepage URL
kazuyatateishi0926@gmail.com
Sponsor or person
Institute
Chiba university hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 05 | 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
| 2017 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 09 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 20 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 05 | Day |
Last modified on
| 2019 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032138
