UMIN-CTR Clinical Trial

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
Email	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
Email	asadato@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University, Faculty of Medicine Department of Neurosurgery
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025922