UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005152 |
|---|---|
| Receipt number | R000006119 |
| Scientific Title | Japan Trial of Pitavastatin for Vein Graft Stenosis on Vascular Surgery |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2018/08/22 10:24:39 |
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Basic information
Public title
Japan Trial of Pitavastatin for Vein Graft Stenosis on Vascular Surgery
Acronym
JAGUAR Study
Scientific Title
Japan Trial of Pitavastatin for Vein Graft Stenosis on Vascular Surgery
Scientific Title:Acronym
JAGUAR Study
Region
| Japan |
Condition
Condition
vein graft stenosis
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of HMG-CoA reductase inhibitor on vein graft stenosis in the patients received autogenous arterial reconstructions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary patency of the vein graft
Key secondary outcomes
Secondary patency of the vein graft, the number of revision operation times , and occurrence events as below;
1)graft obstruction
2)major amputation
3)overall mortality
4)cardiovascular events
5)stroke
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pitavastatin group
Interventions/Control_2
non-statin group
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
Patients after autogenous arterial reconstructions for ASO and with necessity for any treatment on their LDL cholesterol.
Key exclusion criteria
Patients who
(1)received revision surgeries over two times within 48 hrs.
(2)is unfinished their planned bypass surgery.
(3)have took HMG-CoA reductase inhibitor before the bypass surgery.
(4)have malignant tumor in active phase.
(5)have been undergone PCI or CABG for CAD.
(6)meet the contraindication of the drugs using in this study.
(7)is undergoing dialysis.
(8)cannot stop taking the prohibited drugs in this study.
(9)cannot change taking the anti platelet agents to aspirin.
(10)are ineligible in the opinion of the investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadahiro Sasajima |
Organization
Asahikawa Medical University
Division name
Department of Vascular Surgery
Zip code
Address
2-1-1-1 Midorigaoka-higasi Asahikawa, Hokkaido, Japan
TEL
0166-68-2494
ys02067@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Saito |
Organization
Asahikawa Medical University
Division name
Department of Vascular Surgery
Zip code
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2494
Homepage URL
http://www.asahikawa-med-surgery.net/jp/home/index.html
ys02067@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan INC.
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2011 | Year | 03 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | 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
| 2011 | Year | 02 | Month | 28 | Day |
Last modified on
| 2018 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006119
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
