UMIN-CTR Clinical Trial

Basic information
Public title	Association between aspirin dose and outcomes in patients with acute Kawasaki disease
Acronym	Association between aspirin dose and outcomes in patients with acute Kawasaki disease
Scientific Title	Association between aspirin dose and outcomes in patients with acute Kawasaki disease
Scientific Title:Acronym	Association between aspirin dose and outcomes in patients with acute Kawasaki disease
Region	Japan

Condition
Condition	Kawasaki disease
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Using a Japanese national inpatient database, this study aimed to identify the appropriate dose of aspirin to be prescribed to patients with acute Kawasaki disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome was the occurrence of CAAs upon discharge. CAAs were identified with a recorded diagnosis of CAAs (ICD-10 code: I25.4) and/or text data of CAAs in the Japanese language.
Key secondary outcomes	The secondary outcomes were IVIG resistance, length of stay, medical costs, and adverse events.

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
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	3 months-old <=
Age-upper limit	6 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient treated by IVIG
Key exclusion criteria	Patient doesn't treated by IVIG
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Takanori Middle name Last name Suzuki
Organization	Fujita Health University
Division name	Department of pediatrics
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL	+819025786815
Email	takanori-s@axel.ocn.ne.jp

Public contact
Name of contact person	1st name Takanori Middle name Last name Suzuki
Organization	Fujita Health Universty
Division name	Department of pediatrics
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL	+819025786815
Homepage URL
Email	takanori-s@axel.ocn.ne.jp

Sponsor
Institute	Fujita health university
Institute
Department

Funding Source
Organization	Fujita Health University
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	The University of Tokyo, Clinical Research Review Board
Address	Office for Human Research Studies Graduate School of Medicine and Faculty of Medicine, The University of Tokyo Faculty of Medicine Bldg.2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel	03-5841-0818
Email	gha10771@gmail.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	2022 Year 11 Month 29 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	10000
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	2022 Year 10 Month 01 Day
Date of IRB	2021 Year 05 Month 19 Day
Anticipated trial start date	2022 Year 10 Month 01 Day
Last follow-up date	2022 Year 11 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No

Management information
Registered date	2022 Year 11 Month 29 Day
Last modified on	2022 Year 11 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056529