UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Stanford type B aortic dissection patients with normally hypotensive medical therapy and pitavastatin treatment effect.
Title of the study (Brief title)	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	Koichi Tabayashi
Organization	Tohoku University, Graduate School of Medicine
Division name	Cardiovascular Surgery
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	Naotaka Motoyoshi
Organization	STANP trial staff
Division name	Cardiovascular Surgery, Tohoku University, Graduate School of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 04 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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