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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000685
Receipt No. R000000821
Scientific Title Stanford type B aortic dissection patients with normally hypotensive medical therapy and pitavastatin treatment effect.
Date of disclosure of the study information 2007/06/01
Last modified on 2018/12/05

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Basic information
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
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

Objectives
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

Assessment
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

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 not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Cardiovascular Surgery, Tohoku University, Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2007 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 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
Other related information

Management information
Registered date
2007 Year 04 Month 18 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000821

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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