UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008207 |
|---|---|
| Receipt number | R000009657 |
| Scientific Title | Prevention of Cholesterol Embolization during Endovascular and Open aneurysm repair with Pitavastatin [PROCEDURE] Study |
| Date of disclosure of the study information | 2012/06/20 |
| Last modified on | 2023/12/27 09:08:20 |
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Basic information
Public title
Prevention of Cholesterol Embolization during Endovascular and Open aneurysm repair with Pitavastatin [PROCEDURE] Study
Acronym
PROCEDURE study
Scientific Title
Prevention of Cholesterol Embolization during Endovascular and Open aneurysm repair with Pitavastatin [PROCEDURE] Study
Scientific Title:Acronym
PROCEDURE study
Region
| Japan |
Condition
Condition
abdominal aortic aneurysm with massive aortic atheroma
Classification by specialty
| Cardiology | Surgery in general | Vascular surgery |
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the dose-dependent effect of Pitavastatin on massive aortic atheroma of abdominal aortic aneurysms
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of atheroma volume
Key secondary outcomes
Complications after abdominal aortic aneurysm repair
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Pitavastatin 1mg
Interventions/Control_2
Pitavastatin 4mg
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with abdominal aortic aneurysm/ iliac aneurysm which have massive aortic atheroma, who fulfill the item (1) to (4) shown below.
(1) patients with massive atheroma
(a) from left subclavian artery to renal artery
more than half of circumstances, more than 5 mm in thickness, and more than 3 cm in length
(b) aneurysmal neck
more than 3/4 of circumstances, more than 5 mm in thickness, and more than 5 mm in length
(2) patients who need lipid-lowering therapy
(3) patients who are scheduled to perform aneurysm repair
(4) Renal function: CKD 1 to 3
Key exclusion criteria
(1) patients who have already prescribed statin
(2) Renal function: CKD 4 and 5
(3) pregnancy
(4) severe liver dysfunction
(5) patients who have had drugs of contraindication
(6) patients of whom the clinical investigator judged as inappropriate for this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Hoshina |
Organization
The University of Tokyo Hospital
Division name
Vascular Surgery
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
TEL
03-5800-8653
traruba@gmail.com
Public contact
Name of contact person
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Hoshina |
Organization
The University of Tokyo Hospital
Division name
Vascular Surgery
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
TEL
03-5800-8653
Homepage URL
traruba@gmail.com
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5800-8653
traruba@gmail.com
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
東京大学医学部附属病院（東京都）、森之宮病院（大阪府）、三井記念病院（東京都）、東京都健康長寿医療センター（東京都）、東京医科歯科大学（東京都）、茨城県立中央病院（茨城県）、東京都立多摩総合医療センター（東京都）、慶応義塾大学病院（東京都）、慈恵会医科大学附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 20 | 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
| 2012 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 19 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009657
