UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050669 |
|---|---|
| Receipt number | R000057728 |
| Scientific Title | Analysis of the association between platelet-aggregation and efficacy and safety after Prasugrel and Clopidogrel administration-A combined analysis of phase III studies in Prasugrel |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2024/03/26 17:35:47 |
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Basic information
Public title
Analysis of the association between platelet-aggregation and efficacy and safety after Prasugrel and Clopidogrel administration-A combined analysis of phase III studies in Prasugrel
Acronym
Analysis of the association between platelet-aggregation and efficacy and safety after Prasugrel and Clopidogrel administration
Scientific Title
Analysis of the association between platelet-aggregation and efficacy and safety after Prasugrel and Clopidogrel administration-A combined analysis of phase III studies in Prasugrel
Scientific Title:Acronym
Analysis of the association between platelet-aggregation and efficacy and safety after prasugrel and Clopidogrel administration
Region
| Japan |
Condition
Condition
Patients with atherothrombotic cerebral infarction or lacunar infarction who are at high risk of recurrent cerebral infarction
Classification by specialty
| Cardiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Combine data from a phase III trial of prasugrel (J303,304,305) to investigate the association between platelet aggregation and efficacy and safety of prasugrel and clopidogrel in patients with atherothrombotic or lacunar infarction who are at high-risk for recurrent cerebral infarction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PRU at 4 weeks after first-dose
Key secondary outcomes
Cumulative incidence of ischemic and bleeding events occurring from the start of study treatment to 48 weeks after first-dose
PRU at 24 weeks after first-dose
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among patients enrolled in J303, 304, 305 studies, patients with atherothrombotic cerebral infarction or lacunar infarction who are at high-risk for recurrent cerebral infarction.
Key exclusion criteria
N/A
Target sample size
2186
Research contact person
Name of lead principal investigator
| 1st name | Yoshi |
| Middle name | |
| Last name | Yasuda |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
yasuda.yoshi.gn@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Abe |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
Homepage URL
hosokawa.jun.vj@daiichisankyo.co.jp
Sponsor or person
Institute
Daiichi Sankyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Kitamachi clinic
Address
1-1-3 Kichijoji Kitamachi, Musashino, Tokyo
Tel
070-5011-8550
shingo-namiki@cmicgroup.com
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
| 2023 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Post-hoc analysis, using data from the phase 3 trials, no new data will be collected.
Management information
Registered date
| 2023 | Year | 03 | Month | 24 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057728
