UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016185 |
|---|---|
| Receipt number | R000018786 |
| Scientific Title | Effects of low dose colchicine on endothelial function in patients with coronary heart diseases |
| Date of disclosure of the study information | 2015/01/13 |
| Last modified on | 2015/01/12 11:57:58 |
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Basic information
Public title
Effects of low dose colchicine on endothelial function in patients with coronary heart diseases
Acronym
Low dose colchicine and endothelial function
Scientific Title
Effects of low dose colchicine on endothelial function in patients with coronary heart diseases
Scientific Title:Acronym
Low dose colchicine and endothelial function
Region
| Japan |
Condition
Condition
Patients with stable coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of our study is a translational research of colchicine, which already has long history as an anti-gout drug, for the development as an anti-atherosclerotic drug. The present study will examine effects of multiple dose (7 days) of colchicine on endothelial function in patients with coronary artery diseases in a cross over design as a pilot study for pre-phase III study evaluating effects of colchicine on endothelial function in RCT under the ICH-GCP.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Endothelial function measured by FMD.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Colchicine at 0.5mg per day for 1 week
Interventions/Control_2
Placebo
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with coronary artery disease with condition being stable for previous 6 months.
2) Aged 20 years and over and less than 70 years old
3) Patients who voluntarily give informed consent after full explanation of the study
Coronary artery disease is defined as 1)significant stenosis (>AHA 75% ) of coronary arteries by CAG or coronary artery CT 2) history of PCI or CABG 3) history of acute coronary syndrome
Key exclusion criteria
1) Patients aged 70 and over and less than 20 years old
2) Patients receiving drugs interacting with colchicine through CYP3A4 and p-glycoprotein listed in the label.
3) Patients with impaired renal function being eGFR less than 30ml/min/1.73m2
4) Patients with liver cirrhosis
5) Patients with cholestasis
6) Patients with active malignant tumor
7) Patients who are expected mothers or on breast feeding.
8) Inappropriate patients for this study judged by doctors in charge.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Ueda |
Organization
University of the Ryukyus
Division name
Department of Clinical Pharmacology & Therapeutics
Zip code
Address
207 Uehara, Nishiharacho, Okinawa, Japan
TEL
0988951195
blessyou@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Ueda |
Organization
University of the Ryukyus
Division name
Department of Clinical Pharmacology & Therapeutics
Zip code
Address
207 Uehara, Nishiharacho, Okinawa, Japan
TEL
0988951195
Homepage URL
blessyou@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
Grant-in-aid for scientific research from Ministry of health, labor and welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Medical University, HIroshima University
Name of secondary funder(s)
N/A
IRB Contact (For public release)
Organization
Address
Tel
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
琉球大学（沖縄県），東京医科大学（東京都）、広島大学（広島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 13 | 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
| 2014 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 12 | Day |
Last modified on
| 2015 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018786
