UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039190 |
|---|---|
| Receipt number | R000044694 |
| Scientific Title | SAIreito Reduces Early recurrence after Intervention for aTrial fibrillation, Or not study |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2022/02/18 19:50:57 |
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Basic information
Public title
The Prospective Randomized Controlled Trial Evaluating Efficacy of Saireito for Early Rcurrence after Catheter Ablation for Atrial Fibrillation
Acronym
Saireito in Catheter Ablation for Atrial Fibrillation
Scientific Title
SAIreito Reduces Early recurrence after Intervention for aTrial fibrillation, Or not study
Scientific Title:Acronym
SAIREITO study
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of Saireito in early recurrence after catheter ablation for atrial fibrillation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Early recurrence (atrial arrhythmia recurrence within 90 days) after catheter ablation for atrial fibrillation
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intake of saireito for 1 month after ablation procedure
Interventions/Control_2
Control (No Saireito)
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
| 21 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing first catheter ablation including PV isolation for symptomatic atrial fibrillation
Patients who are 21-85 years old
Able to be followed for one year in an out-patient clinic
Willing to sign the consent form for participation
Key exclusion criteria
Patients who previously received ablation procedure surgical MAZE procedure for AF
Contraindication or intolerance to Saireito, including severe interstitial pneumonitis, and aldosteronism
Patients who already take Saireto at the time of procedure
Renal insufficiency (estimated Glomerular Filtration Rate <30 or hemodialysis)
Patients who received immunosuppressants (PSL or infliximab, etc)
Liver insufficiency
When the attending physician consider inappropriate to enroll the patient in the study
Unwilling to sign the consent form for participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Shizuta |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075(381)2111
tyokoma22@iris.eonet.ne.jp
Public contact
Name of contact person
| 1st name | Tetsuma |
| Middle name | |
| Last name | Kawaji |
Organization
Mitsubishi Kyoto Hospital
Division name
Department of Cardiology
Zip code
615-8087
Address
1 Katsura Gosho-cho, Nishikyo-ku, Kyoto
TEL
075(381)2111
Homepage URL
kawaji@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine,Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Operation cost grant
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
Ethics Committee, Kyoto University Graduate School of Medicine
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
Tel
075(751)3111
ethcom@kuhp.kyoto-u.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
京都大学医学部附属病院(京都)、三菱京都病院（京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 17 | Day |
Last modified on
| 2022 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044694
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| Registered date | File name |
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