UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Candesartan may prevent aneurysmal changes in the residual native aorta after thoracic aortic aneurysm surgery
Title of the study (Brief title)	CAPTAIN Study
Region	Japan

Condition
Condition	Thoracic aortic aneurysm
Classification by specialty	Cardiology Vascular surgery Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether or not angiotensin receptor blocker can exert a role to prevent aneurysmal changes in the residual aorta after thoracic aortic surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in the aortic diameter
Key secondary outcomes	Pulse wave velocity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of Cnadesartan
Interventions/Control_2	Administration of antihypertensive drug other than Candesartan
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	Patients with hypertention who underwent thoracic aortic surgery
Key exclusion criteria	Patients with contraindication for Candesartan Patients with allergic reaction to Candesartan Pregnant or potentially pregnant Patients who did not consent to the study Patients under 20 years of age Others who are not suitable to the enrollment from the physician's point of view
Target sample size	150

Research contact person
Name of lead principal investigator	Koichi Tabayashi
Organization	Graduate School of Medicine, Tohoku University
Division name	Department of Cardiovascular Surgery
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-7222
Email	konosuke.s@med.tohoku.ac.jp

Public contact
Name of contact person	Yoshikatsu Saiki
Organization	Graduate School of Medicine, Tohoku University
Division name	Department of Cardiovascular Surgery
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-7222
Homepage URL
Email	ysaiki@mail.tains.tohoku.ac.jp

Sponsor
Institute	Graduate School of Medicine, Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 06 Month 30 Day
Anticipated trial start date	2007 Year 11 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2007 Year 06 Month 28 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=R000000908