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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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20 November 2023 |
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Main ID: |
JPRN-UMIN000025936 |
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Date of registration:
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20/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Japanese AntibaCterial drug maNagemEnt for cardiac Sarcoidosis Trial
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Scientific title:
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Japanese AntibaCterial drug maNagemEnt for cardiac Sarcoidosis Trial - J-ACNES |
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Date of first enrolment:
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2017/06/12 |
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Target sample size:
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80 |
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Recruitment status: |
Complete: follow-up continuing |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029819 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kengo
Kusano |
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Address:
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6-1 Kishibeshinmachi, Suita, Osaka, Japan
Japan |
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Telephone:
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0661701070 |
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Email:
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kusanokengo@gmail.com |
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Affiliation:
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National cerebral and cardiovascular center department of cardiovascular medicine |
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Name:
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Kengo
Kusano |
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Address:
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6-1 Kishibeshinmachi, Suita, Osaka, Japan
5648565
Japan |
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Telephone:
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0661701070 |
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Email:
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kusanokengo@gmail.com |
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Affiliation:
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National cerebral and cardiovascular center department of cardiovascular medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: liver or kideny dysfunction, active infection, contraindication of drugs, corticosteroid therapy within 6 months for other disease, severe diabetes mellitus, and pregnancy
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Cardiac sarcoidosis
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Intervention(s)
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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.
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Primary Outcome(s)
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the change of SUV level from baseline in FDG-PET/CT examination (6 months after study enroll)
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Secondary Outcome(s)
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the frequency of steroid dose increasing (12 months after study enroll)
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Source(s) of Monetary Support
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National cerebral and cardiovascular center
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Ethics review
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Status: YES
Approval date: 12/12/2016
Contact:
rec-office-ac@ncvc.go.jp
National cerebral and cardiovascular center research ethics committee
0661701070
rec-office-ac@ncvc.go.jp
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Results
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Results available:
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Yes |
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Date Posted:
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09/02/2023 |
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Date Completed:
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30/09/2021 |
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URL:
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