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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name