UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007897 |
|---|---|
| Receipt number | R000008947 |
| Scientific Title | Effects of oral small spherical activated charcoal (Kremezin) on inflammatory cytokines and coronary plaque component assessed by integrated backscatter intravascular ultrasound |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2012/12/25 22:02:02 |
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Basic information
Public title
Effects of oral small spherical activated charcoal (Kremezin) on inflammatory cytokines and coronary plaque component assessed by integrated backscatter intravascular ultrasound
Acronym
Antiarteriosclerotic effect of oral small spherical activated charcoal (Kremezin)
Scientific Title
Effects of oral small spherical activated charcoal (Kremezin) on inflammatory cytokines and coronary plaque component assessed by integrated backscatter intravascular ultrasound
Scientific Title:Acronym
Antiarteriosclerotic effect of oral small spherical activated charcoal (Kremezin)
Region
| Japan |
Condition
Condition
chronic renal failure patients( eGFRis less than 45 ml/min/1.73m2)
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine effects of Kremezin on inflammatory cytokines and coronary plaque component assessed by integrated backscatter intravascular ultrasound
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
tissue characterization of coronary plaque
levels of inflammatory cytokine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1)Tissue characteristics of coronary plaques and levels of inflammatory cytokines were examined
2) Kremezin was added
3)Tissue characteristics of the same coronary plaques and levels of inflammatory cytokines were examined 6 months after first IB-IVUS examination
Interventions/Control_2
1)Tissue characteristics of coronary plaques and levels of inflammatory cytokines were examined
2)no additional drugs were added
3)Tissue characteristics of the same coronary plaques and levels of inflammatory cytokines were examined 6 months after first IB-IVUS examination
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients with stable angina planned to be treated with stent
2)Chronic renal failure patients (eGFR<45ml/min/1.73m2)
3)Patients who had been treated with statin(LDL-cho< 100mg/dl)
4)written informed consent before the
Key exclusion criteria
1)Dialysis patients
2)Patients with cancer
3)Patients with a history of coronary artery bypass surgery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Sata |
Organization
Tokushima university hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-50-1 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokushima university hospital
Division name
Division of cardiology
Zip code
Address
TEL
Homepage URL
yamakoji3@hotmail.com
Sponsor or person
Institute
Tokushima university 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
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 07 | Day |
Last modified on
| 2012 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008947
