UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025405 |
|---|---|
| Receipt number | R000025922 |
| Scientific Title | Open trial of combined use of Prasugrel for the prevention of thromoembolic complication in endovascular surgery of cerebral aneursyms |
| Date of disclosure of the study information | 2016/12/26 |
| Last modified on | 2020/07/08 12:37:36 |
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Basic information
Public title
Open trial of combined use of Prasugrel for the prevention of thromoembolic complication in endovascular surgery of cerebral aneursyms
Acronym
Antithrombotic effect of Prasugrel in endovascular surgery of cerebral aneurysms
Scientific Title
Open trial of combined use of Prasugrel for the prevention of thromoembolic complication in endovascular surgery of cerebral aneursyms
Scientific Title:Acronym
Antithrombotic effect of Prasugrel in endovascular surgery of cerebral aneurysms
Region
| Japan |
Condition
Condition
unruptured cerebral aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make antiplatelet therapy in endovascular surgery of cerebral aneurysms more effective and safe
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of clinical thromboembolic and hemorrhagic complication
Key secondary outcomes
Frequency of thromboembolic complication detected by MRI(Diffusion Weighted Image) within postoperative 5 days.
Frequency of cerebral infarction and hemorrhagic complication on brain CT scan at 2~4 weeks after the endovascular surgery
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standard prescription (Aspirin 100mg/day and Clopidogrel 75mg/day) are started 2 weeks before the endovascular surgery. Platelet function is checked on the day before the surgery. Patient with low~no response to Clopidogrel is changed to Prasugrel (loading dose 20mg, then, 3.75mg/day for 3 days). When stent is used, Prasugrel is contineud for 3 months.
Interventions/Control_2
Clopidogrel is continued for patient with normal response to Clopidogrel (75mg/day for 3 days). When stent is used, Clopidogrel is contineud for 3 months.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who provide informed consent for the trial.
2. Patients who are no~low response to Clopidogrel
Key exclusion criteria
1. Patinets who are treated with anticoagulation drugs (warfarin and NOAC) and /or antiplatelet drugs other than Aspirin and Clopidogrel.
2. Patients with abnormal platelet count (<50000/microL)
3. Patients with active bleeding (GI tract, etc)
4. Patients who are allergic to Prasugrel
5. Patients who are indicated for parent artery occlusion
6. Patients who are considered unsuitable for the trial by the responsible researcher.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akiyo |
| Middle name | |
| Last name | Sadato |
Organization
Fujita Health University, Faculty of Medicine
Division name
Department of Neurosurgery
Zip code
470-1192
Address
Kutsukake-cho, Dengakugakubo 1-98, Toyoake city, Aichi Japan 470-1192
TEL
0562939253
asadato@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Akiyo |
| Middle name | |
| Last name | Sadato |
Organization
Fujita Health University, Faculty of Medicine
Division name
Department of Neurosurgery
Zip code
470-1192
Address
Kutsukake-cho, Dengakugakubo 1-98, Toyoake city, Aichi Japan 470-1192
TEL
0562-93-9253
Homepage URL
asadato@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University, Faculty of Medicine
Department of Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University, Faculty of Medicine
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
Fujita health university institusional review board
Address
Kutsukake-cho, Dengakugakubo 1-98, Toyoake city, Aichi Japan 470-1192
Tel
0562932865
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 26 | 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
167
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
| 2015 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | 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 | 12 | Month | 26 | Day |
Last modified on
| 2020 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025922
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
