UMIN-CTR Clinical Trial

Public title

Stanford type B aortic dissection patients with normally hypotensive medical therapy and pitavastatin treatment effect.

Acronym

Stanford type B aortic dissection patients with pitavastatin treatment trial (STANP trial)

Scientific Title

Stanford type B aortic dissection patients with normally hypotensive medical therapy and pitavastatin treatment effect.

Scientific Title:Acronym

Stanford type B aortic dissection patients with pitavastatin treatment trial (STANP trial)

Region

Japan

Condition

Stanford type B acute aortic dissection patients transported within 48 hours of symptom onset , adaptable normally hypotensive medical therapy.

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of HMG-CoA reductase inhibitor therapy for aortic dissection patients in multiple institutions.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Percent change and absolute change in the total diameter of the descending aorta (minor axis) by CT angiography

Key secondary outcomes

Percent change and absolute change in the following items
(1)Threatened rupture
(2)Surgical operation
(3)Serum lipid profile (LDL-C, triglyceride, HDL-C)
(4)Serum creatinine
(5)Correlation with the total diameter of descending aorta (minor axis) and serum lipid profile or serum creatinine
(6)All-cause mortalities
(7)Evaluation of adverse events
(8)Laboratory test abnormalities

Study type

Interventional

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 not considered as adjustment factor.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Standard hypotensive medical therapy with pitavastatin 2 mg daily for a period of 12 months

Interventions/Control_2

Standard hypotensive medical therapy for a period of 12 months

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Stanford type B acute aortic dissection patients transported within 48 hours after onset.
(2) Standard hypotensive medical therapy
(3) Greater than 20 years old at time of consent.
(4) Provide voluntary written informed consent for participation in the study after being fully informed.

Key exclusion criteria

(1) Patients with the total diameter of descending aorta (minor axis) by CT angiography more than 50mm.
(2) Marfan's syndrome patients
(3) Patients with continuous pain.
(4) Patients with unstable vital signs.
(5) Patients with signs or symptoms of organ ischemia
(6) Fasting serum levels of TC >/= 250 mg/dL.
(7) Known hypersensitivity or history of clinically significant adverse reactions to any component of study drugs.
(8) Patients with hepatopathy (ALT >/=100 IU/L) or biliary obstruction with the following conditions - acute hepatitis, acute exacerbation of chronic hepatitis, hepatic cirrhosis, hepatoma, jaundice.
(9) Pregnant, possibly pregnant, or lactating.
(10) Patients with significant renal dysfunction (serum creatinine >/= 2.0 mg/dL) or renal dialysis.
(11) Patient who is judged by the investigator to be inappropriate for inclusion in the study.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Koichi Tabayashi

Organization

Tohoku University, Graduate School of Medicine

Division name

Cardiovascular Surgery

Zip code

Address

2-1, SEIRYO-CHO, AOBAKU, SENDAI, MIYAGI 980-8575

TEL

022-717-7222

Email

konosuke.s@med.tohoku.ac.jp

Name of contact person

1st name
Middle name
Last name	Naotaka Motoyoshi

Organization

STANP trial staff

Division name

Cardiovascular Surgery, Tohoku University, Graduate School of Medicine

Zip code

Address

2-1, SEIRYO-CHO, AOBAKU, SENDAI, MIYAGI 980-8575

TEL

022-717-7222

Homepage URL

Email

motoyoshi_n810@yahoo.co.jp

Institute

Cardiovascular Surgery, Tohoku University, Graduate School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2007

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2007

Year

04

Month

02

Day

Date of IRB

Anticipated trial start date

2007

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2007

Year

04

Month

18

Day

Last modified on

2018

Year

12

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000821