UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective exploratory study on the effect of oral administration of apixaban in vascular endothelial function in patients with non-valvular atrial fibrillation
Title of the study (Brief title)	Prospective study on the effect of apixaban on vascular endothelial function
Region	Japan

Condition
Condition	Non-valvular atrial fibrillation patients
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the present study, it is prospectively examined whether improvement of vascular endothelial function by oral administration of new anticoagulant for patients with non-valvular atrial fibrillation using EndoPAT (manufactured by Itamar medical), and also examined the relationship of inflammatory response, vascular endothelial function, coagulation fibrinolytic marker using blood collection and urine analysis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	vascular endothelial function
Key secondary outcomes	Lab test (General peripheral blood, total protein, albumin, CK, Cr, AST, ALT, gamma-GTP, TG, LDL, HDL, oxidant LDL, hs TNF-alfa, IL-6, Adiponectin, Thrombomodulin, hs CRP, ADMA, Insulin, fibrinogen, D-dimer, TAT, PIC, F1+2, PAI-1, BNP, 8-OHdG/CRE)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	single arm study, open(masking not used),uncontrolled control, single assignment, treatment purpose
Interventions/Control_2
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects are 50 patients that consented for consecutive cases of eligible non-valvular atrial fibrillation patients (at least 15 paroxysmal atrial fibrillation cases and at least 15 sustained atrial fibrillation cases). Also, more than 5 subjects with 2 CHADS2 scores and more than 5 subjects with 3 or more CHADSS2 scores are entered respectively.
Key exclusion criteria	1) Patients contraindicated for anticoagulant drug 2) Patients complicated of malignant tumor 3) Patients who have orally ingested anticoagulant within 6 months 4) Patients who judged ineligible from the examining physician
Target sample size	50

Research contact person
Name of lead principal investigator	Taro Adachi
Organization	Showa University School of Medicine
Division name	Division of Cardiology, Department of Medicine
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8539
Email	adachitaro@med.showa-u.ac.jp

Public contact
Name of contact person	Taro Adachi
Organization	Showa University School of Medicine
Division name	Division of Cardiology, Department of Medicine
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8539
Homepage URL
Email	adachitaro@med.showa-u.ac.jp

Sponsor
Institute	Showa University School of Medicine
Institute
Department

Funding Source
Organization	Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization	Profit organization
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	2019 Year 02 Month 18 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 05 Month 16 Day
Anticipated trial start date	2018 Year 05 Month 16 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	2019 Year 02 Month 18 Day
Last modified on	2019 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040904