Unique ID issued by UMIN | UMIN000025936 |
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Receipt number | R000029819 |
Scientific Title | Japanese AntibaCterial drug maNagemEnt for cardiac Sarcoidosis Trial |
Date of disclosure of the study information | 2017/02/20 |
Last modified on | 2023/08/07 14:02:47 |
Japanese AntibaCterial drug maNagemEnt for cardiac Sarcoidosis Trial
J-ACNES
Japanese AntibaCterial drug maNagemEnt for cardiac Sarcoidosis Trial
J-ACNES
Japan |
Cardiac sarcoidosis
Cardiology |
Others
NO
the evaluation of safety and efficacy between standard therapy (steroid only) and combination therapy (steroid + clarithromycin + doxycycline) for cardiac sarcoidosis patient
Safety,Efficacy
the change of SUV level from baseline in FDG-PET/CT examination (6 months after study enroll)
the frequency of steroid dose increasing (12 months after study enroll)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
combination therapy group:
Prednisolone; Predonisolone start from 30mg/day and continue same dose for one month. After one month, prednisolone decrease 25mg, 20mg, 15mg, 10mg every 2-4 weeks. Finally, maintenance dose of predonisolone is 7.5mg.
Antimicrobial agent; Clarithromycin start from 400mg/day for 24weeks. Doxycycline start 100mg/day for 22 weeks after 2 months of clarithromycin therapy.
Prednisolone; Predonisolone start from 30mg/day and continue same dose for one month. After one month, prednisolone decrease 25mg, 20mg, 15mg, 10mg every 2-4 weeks. Finally, maintenance dose of predonisolone is 7.5mg.
20 | years-old | <= |
Not applicable |
Male and Female
Cardiac sarcoidosis patient who have positive finding of FDG-PET and/or Ga scintigram and indication of steroid therapy.
liver or kideny dysfunction, active infection, contraindication of drugs, corticosteroid therapy within 6 months for other disease, severe diabetes mellitus, and pregnancy
80
1st name | Kengo |
Middle name | |
Last name | Kusano |
National cerebral and cardiovascular center
department of cardiovascular medicine
5648565
6-1 Kishibeshinmachi, Suita, Osaka, Japan
0661701070
kusanokengo@gmail.com
1st name | Kengo |
Middle name | |
Last name | Kusano |
National cerebral and cardiovascular center
department of cardiovascular medicine
5648565
6-1 Kishibeshinmachi, Suita, Osaka, Japan
0661701070
kusanokengo@gmail.com
National cerebral and cardiovascular center
National cerebral and cardiovascular center
Self funding
National cerebral and cardiovascular center research ethics committee
6-1 Kishibeshinmachi, Suita, Osaka, Japan
0661701070
rec-office-ac@ncvc.go.jp
NO
2017 | Year | 02 | Month | 20 | Day |
Unpublished
29
Analyzing
2023 | Year | 02 | Month | 09 | Day |
Delay expected |
analyzing
cardiac sarcoidosis
Adverse event 12events(included 7serious adverse events)
Change from baseline in total SUV by FDG-PET/CT (at 6 months after administration)
No longer recruiting
2016 | Year | 12 | Month | 07 | Day |
2016 | Year | 12 | Month | 12 | Day |
2017 | Year | 06 | Month | 12 | Day |
2021 | Year | 09 | Month | 30 | Day |
2022 | Year | 09 | Month | 30 | Day |
2017 | Year | 01 | Month | 31 | Day |
2023 | Year | 08 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029819
Research Plan | |
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Registered date | File name |
2018/08/08 | J-ACNES試験_臨床試験実施計画書第2.5版2018年7月9日.docx |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |