臨床研究等提出・公開システム

Japanese

Date of registration	July. 30, 2020
Last modified on	Dec. 01, 2024
Trial ID	jRCTs051200037

Scientific Title	he Prospective Randomized Controlled Trial Evaluating Efficacy of Saireito for Early Rcurrence after Catheter Ablation for Atrial Fibrillation (SAIREITO study)
Public Title	Saireito in Catheter Ablation for Atrial Fibrillation (SAIREITO study)

Completion date	Feb. 01, 2024
Result actual enrolment	100
Baseline Characteristics	Age was about 70 years old. The pevalence of female and paroxysmal AF the was 47% and 82%. Median AF duration was about 0.7%
Participant flow	One hundred patients who underwent catheter ablation of symptomatic AF were randomly assigned to either a 30-day use of Saireito or control group (each N=50).
Adverse events	The prevalence of adverse symptoms such as a cough and digestive symptoms over 30 days was significantly higher in the Saireito group(18.0% versus 2.0%, P=0.005)
Outcome measures	The Saireito group patients were associated with a relatively, but not significantly, lower prevalence of frequent atrial tachyarrhythmias than the control group during the 30-day treatment period(3.1times versus 5.2times, P=0.17). The mean daily incidence was significantly lower during 6 to 10-day(0.12times/day and 0.27times/day, P=0.03), and during 11 to 15-day post-procedure(0.08times/day and 0.24times/day, P=0.001)
Brief summary	Thirty-day use of Saireito following AF catheter ablation did not reduce frequent atrial tachyarrhythmias during the treatment period, but the favorable effect was remarkable in the first 2 weeks. However, it was associated with a higher prevalence of adverse outcomes.
Date of posting of results summaries	Dec. 01, 2024
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	None
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs051200037

Contact for Scientific Queries	Name	Shizuta Satoshi
	Affiliation	Kyoto University Hospital
	Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
	Telephone	+81-75-751-4254
	E-mail	shizuta@kuhp.kyoto-u.ac.jp
Contact for Public Queries	Name	Kawaji Tetsuma
	Affiliation	Kyoto University Graduate School of Medicine
	Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
	Telephone	+81-75-751-4255
	E-mail	kawaji@kuhp.kyoto-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		July. 30, 2020
Actual date of first enrollment		Aug. 05, 2020
Target sample size		100
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	First time ablation procedure for symptomatic atrial fibrillation Patients who can be followed for 1-year after procedure Patients from who we get written informed consent
	Exclusion Criteria	Severe complications of ablation procedure Patients who received ablation procedure or MAZE procedure for for atrial fibrillation before enrollment Patients who already take Saireito Chronic kidney disease (eGFR<30 or hemodialysis) Chronic liver failure Patients who can not take Saireito
	Age Minimum	21age old over
	Age Maximum	85age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Atrial fibrillation
Intervention(s)		Intake of saireito for 1 month after ablation procedure
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code		D001281
Intervention(s) Code		D004364
Primary Outcome(s)		Early recurrence (atrial arrhythmia recurrence within 90 days) after catheter ablation for atrial fibrillation
Secondary Outcome(s)		Adverse events within 30 days after procedure QOL score at 30-day Change of cardiac, inflammation, renal biomarker (TnI,CRP,NGAL) Atrial arrhythmia recurrence beyond 90 days after catheter ablation for atrial fibrillation

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Operation Cost Grant
Secondary Sponsor	Applicable

Name of Certified Review Board	Kyoto University Certified Review Board
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN, Kyoto
Telephone	+81-75-753-4680
E-Mail	ethcom@kuhp.kyoto-u.ac.jp
Approval Status	Approval
Date of approval	May. 11, 2020

Secondary ID(s)	UMIN000039190
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Dec. 01, 2024	(this page)	Changes
4	Mar. 08, 2022	Detail	Changes
3	April. 05, 2021	Detail	Changes
2	Aug. 20, 2020	Detail	Changes
1	July. 30, 2020	Detail

List of change history