UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective study of the inhibitory effect of paroxetine on the cerebral aneurysm growth and recurrence after endovascular treatment for cerebral aneurysms
Acronym	Drug for aneurysm study
Scientific Title	Retrospective study of the inhibitory effect of paroxetine on the cerebral aneurysm growth and recurrence after endovascular treatment for cerebral aneurysms
Scientific Title:Acronym	Drug for aneurysm study
Region	Japan

Condition
Condition	cerebral aneurysm
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The rupture of a cerebral aneurysm is a major cause of life-threatening subarachnoid hemorrhages. Currently, there are surgical interventions but no effective drug treatment for cerebral aneurysms. We hypothesized that cerebral aneurysms are induced when endothelial cells sense an increase in wall shear stress and respond by triggering the induction of biochemical mediators which damage the vascular wall components, thereby giving rise to the cerebral aneurysm. P2X4 purinoceptor is involved in the shear stress response of vascular endothelial cells, contributing to vascular remodeling. Using P2X4 knockout mice and P2X4 inhibitor, paroxetine, we indicated that both the disruption and inhibition of P2X4 resulted in a significant reduction of cerebral aneurysm induction. The larger the cerebral aneurysm, the easier it is to rupture, and by suppressing its growth, the rupture rate can be reduced. Therefore, paroxetine may be able to diminish rupture by suppressing aneurysm growth. Paroxetine may have potential for the clinical treatment of cerebral aneurysm, since this agent exhibits efficacy as a clinical antidepressant. We thus retrospectively examine whether the growth of aneurysms and recurrence after coil embolization can be suppressed by paroxetine.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To compare the rate of cerebral aneurysm growth between unruptured cerebral aneurysms who were taking paroxetine and those who were not taking paroxetine.
Key secondary outcomes	To compare the postoperative recanalization rate between patients who underwent coil embolization of a cerebral aneurysm who were taking paroxetine and those who were not taking paroxetine.

Base
Study type	Observational

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
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Interventions/Control_8
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Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Unruptured saccular cerebral aneurysm with a major axis of 3 mm or more or saccular cerebral aneurysm with a major axis of 3 mm or more that underwent coil embolization (ruptured and unruptured cerebral aneurysm) (2) Cases in which cerebrovascular imaging (MRA, 3DCTA, or cerebrovascular angiography) has been performed at least twice (3) Cases in which the interval between the first and final cerebrovascular imaging tests is at least half a year (4) Cases in which paroxetine was continuously taken during the first and final cerebrovascular imaging examinations, and cases in which paroxetine was not taken at all in the control group during the period. (5) In cases of coil embolization, cases in which cerebrovascular imaging at the time of surgery can be obtained (6) Cases aged 20 years or older at the time of the first cerebrovascular imaging test
Key exclusion criteria	(1) Cases of dissecting cerebral aneurysm (2) Cases of bacterial cerebral aneurysm (3) Cases of cerebrovascular imaging test results where the size of the cerebral aneurysm and the presence or absence of recurrence after coil embolization cannot be determined (4) Cases in which the principal investigator or the research coordinator judged that participation in this study was not appropriate
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Youko Middle name Last name Niwa
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Neurosurgery
Zip code	612-8555
Address	1-1, Mukaihara-cho, Fukakusa, Fushimi-ku, Kyoto City
TEL	075-641-9161
Email	yniwa@hotmail.com

Public contact
Name of contact person	1st name Drug for aneurysm Study Middle name Last name Secretariat
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Neurosurgery
Zip code	612-8555
Address	1-1, Mukaihara-cho, Fukakusa, Fushimi-ku, Kyoto City
TEL	075-641-9161
Homepage URL
Email	drug.for.aneurysm@gmail.com

Sponsor
Institute	National Hospital Organization
Institute
Department

Funding Source
Organization	National Hospital Organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	J-ASPECT Study
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Hospital Organization
Address	2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel	03-5712-5050
Email	700-kenkyu@mail.hosp.go.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	2020 Year 10 Month 14 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	2020 Year 09 Month 23 Day
Date of IRB
Anticipated trial start date	2020 Year 10 Month 31 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Image data, case background and imaging test information

Management information
Registered date	2020 Year 10 Month 14 Day
Last modified on	2020 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048049