UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041992 |
|---|---|
| Receipt number | R000047924 |
| Scientific Title | Efficacy and safety of low dose Colchicine in patients with atherothrombotic brain infarction and gout or hyperuricemia |
| Date of disclosure of the study information | 2020/10/03 |
| Last modified on | 2023/10/06 14:25:19 |
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Basic information
Public title
Efficacy and safety of low dose Colchicine in patients with atherothrombotic brain infarction and gout or hyperuricemia
Acronym
Efficacy and safety of low dose Colchicine in patients with atherothrombotic brain infarction and gout or hyperuricemia
Scientific Title
Efficacy and safety of low dose Colchicine in patients with atherothrombotic brain infarction and gout or hyperuricemia
Scientific Title:Acronym
Efficacy and safety of low dose Colchicine in patients with atherothrombotic brain infarction and gout or hyperuricemia
Region
| Japan |
Condition
Condition
atherothrombotic brain infarction
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects and long-term safety of Colchicine in patients with atherothrombotic brain infarction and gout or hyperuricemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary efficacy endpoint is the first occurrence of an event of ischemic stroke recurrence during the first 12th month after treatment.
The primary safety endpoint was to evaluate any adverse events and the Colchicine related side effects during the observation period.
Key secondary outcomes
Myocardial infarction, or stroke, infection, and total mortality during the first 12th month after treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Colchicine 0.5 mg per day for 12 months in addition to standard treatment
Interventions/Control_2
standard treatment
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
| 20 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Within 7 days of onset.
2.atherothrombotic brain infarction.
3.capable and willing to provide written informed consent.
4.Colchicine receiving group should have a history of gout or uric acid level of more than 8.0 mg per dl after hospitalization.
Key exclusion criteria
1.pre mRS more than 3
2.Have a potential cardiac source of embolism
3.suspect of arterial dissection.
4.unavailable to MRI.
5.Life expectancy less than 1 year.
6.Contraindicated for Colchicine.
7.Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Daiki |
| Middle name | |
| Last name | Fukunaga |
Organization
Japanese Red Cross Kyoto Daini Hospital
Division name
Department of Neurology
Zip code
602 8026
Address
355 5 Haruobicho Kamigyoku. Kyoto Japan
TEL
0752315171
d-fuku@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | Fukunaga |
| Last name | Fukunaga |
Organization
Japanese red cross Kyoto daini hospital
Division name
Department of Neurology
Zip code
602 8026
Address
355 5 Haruobicho Kamigyoku. Kyoto Japan
TEL
0752315171
Homepage URL
d-fuku@koto.kpu-m.ac.jp
Sponsor or person
Institute
Japanese Red Cross Kyoto Daini Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Japanese red cross Kyoto daini hospital
Address
355 5 Haruobicho Kamigyoku. Kyoto Japan
Tel
0752315171
chiken2@kyoto2.jrc.or.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | 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 | 10 | Month | 02 | Day |
Last modified on
| 2023 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047924
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
