UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation of the tolerability and the cost, due to the drug change to novel oral anticoagurants (rivaroxaban) from warfarin in patients with nonvalvular atrial fibrillation in the perioperative period
Title of the study (Brief title)	The investigation of the tolerability and the cost, due to the drug change to novel oral anticoagurants (rivaroxaban) from warfarin in patients with nonvalvular atrial fibrillation in the perioperative period
Region	Japan

Condition
Condition	Nonvalvular Atrial Fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the tolerability and the cost affected by the oral anticoagurants change to Xarelto from warfarin in patients with nonvalvular atrial fibrillation in the perioperative period
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Inpatient days 2)In-hospital medical expense (including outpatient therapy)
Key secondary outcomes	Tolerability (existence or nonexistence of hemorrhage and orischemic events)

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	Xarelto is administered to patients at the dose of 15mg/day.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)The patients with nonvalvular atrial fibrillation who are scheduled to undergo surgery recommended to use Heparin 2)Patients who received sufficient explanation before participation in this study, understood it and gave written consent based on their free will
Key exclusion criteria	1)The patients with contraindication of Xarelto 2)The patients who are not allowed to participate in the trial by the principal investigator
Target sample size	50

Research contact person
Name of lead principal investigator	Takahisa YAMADA
Organization	Osaka General Medical Center
Division name	Division of Cardiology
Address	3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Email	kenkyusien@gh.opho.jp

Public contact
Name of contact person	Takahisa YAMADA
Organization	Osaka General Medical Center
Division name	Division of Cardiology
Address	3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Homepage URL
Email	kenkyusien@gh.opho.jp

Sponsor
Institute	Osaka General Medical Center
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	2013 Year 07 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 11 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
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	2013 Year 07 Month 03 Day
Last modified on	2019 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013005