UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041992
Receipt No. 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 2020/10/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email d-fuku@koto.kpu-m.ac.jp

Sponsor
Institute Japanese Red Cross Kyoto Daini Hospital
Institute
Department

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
Email 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
2023 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
2020 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047924

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.