UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051622 |
|---|---|
| Receipt number | R000058901 |
| Scientific Title | An open study evaluating clopidogrel and prasugrel in antiplatelet therapy in the acute phase of ischemic stroke by evaluating platelet aggregation inhibitory ability using a narrow mouth suction pressure detection method |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/07/17 00:52:35 |
* 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
An open study evaluating clopidogrel and prasugrel in antiplatelet therapy in the acute phase of ischemic stroke by evaluating platelet aggregation inhibitory ability using a narrow mouth suction pressure detection method
Acronym
An open study evaluating clopidogrel and prasugrel in antiplatelet therapy in the acute phase of ischemic stroke by evaluating platelet aggregation inhibitory ability using a narrow mouth suction pressure detection method
Scientific Title
An open study evaluating clopidogrel and prasugrel in antiplatelet therapy in the acute phase of ischemic stroke by evaluating platelet aggregation inhibitory ability using a narrow mouth suction pressure detection method
Scientific Title:Acronym
An open study evaluating clopidogrel and prasugrel in antiplatelet therapy in the acute phase of ischemic stroke by evaluating platelet aggregation inhibitory ability using a narrow mouth suction pressure detection method
Region
| Japan |
Condition
Condition
cerebral infarction
Transient ischemic attack
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the suppression of platelet aggregation by the antiplatelet drugs clopidogrel and prasugrel, which are used to prevent recurrence of cerebral infarction in the treatment of acute cerebral infarction, using a fine-mouth suction pressure detection method.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1-2 days, 3-4 days, 1 week, 2 weeks, and 1 month after the start of administration of clopidogrel and prasugrel, respectively.
Key secondary outcomes
Number of platelet function-suppressing abilities of bayaspirin between both groups within 30 days after drug administration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Group with multiple risk factors; group A. Start aspirin 100 mg/day plus prasugrel 3.75 mg/day.
Interventions/Control_2
group with few risk factors; designated group B. Initiate aspirin 100 mg/day plus clopidogrel 75 mg/day.
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
1.Patients who have given written consent of their own free will after receiving a sufficient explanation before participating in this study.
2. Patients aged 20 years or older at the time of informed consent
3. Patients who are urgently admitted to neurosurgery due to cerebral infarction symptoms or transient ischemic attack
Key exclusion criteria
1. Patients with atrial fibrillation at admission or in the history
2. Cerebral infarction associated with vascular dissection
3. Patients taking concomitant anticoagulants
4. Patients with abnormal platelet count
5. Patients with bleeding such as gastrointestinal bleeding
6. Patients with hypersensitivity to clopidogrel or prasugrel
7. Other patients who are judged to be inappropriate by the principal investigator or co-investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Saeko |
| Middle name | |
| Last name | Higashiguchi |
Organization
Fujita Health University Okazaki Medical Center
Division name
Neurosurgery
Zip code
444-0827
Address
1, Gotanda, Harisaki-cho, Okazaki, Aichi, Japan
TEL
+81-564-64-8133
shigasi@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Saeko |
| Middle name | |
| Last name | Higashiguchi |
Organization
Fujita Health University Okazaki Medical Center
Division name
neurosurgery
Zip code
444-0827
Address
1, Gotanda, Harisaki-cho, Okazaki, Aichi, Japan
TEL
+81-564-64-8133
Homepage URL
https://www.fujita-hu.ac.jp/~neuron/research/research_20230323.html
shigasi@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Saeko HIGASHIGUCHI
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98, Dengakugakubo Kutuskake, Toyoake, Aichi, Japan
Tel
+81-562-93-2865
f-irb@fujita-hu.ac.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
藤田医科大学岡崎医療センター(愛知県)
Other administrative information
Date of disclosure of the study information
| 2024 | 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
13
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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2026 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058901
