UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical efficacy and safety of edoxaban for treatment of chronic thromboembolic pulmonary hypertension
Title of the study (Brief title)	Clinical efficacy and safety of edoxaban for treatment of chronic thromboembolic pulmonary hypertension
Region	Japan

Condition
Condition	CTEPH (chronic thromboembolic pulmonary hypertension)
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clinical evaluation of switching to edoxaban from warfarin on CTEPH
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Clinical worsening events during six months after switching to edoxaban from warfarin on CTEPH
Key secondary outcomes	Evaluation of clinical parameters (Hemodynamics,right heart function, systemic vascular function, oxygenation, exercise capacity, quality of life, coagulation-lysis systems) at 6 months after edoxaban on CTEPH

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Initiation of once-daily Edoxaban(60mg) during 6 months after 2 days discontinuation of warfarin
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)CTEPH was diagnosed with V/Q scintigraphy and/or pulmonary angiography 2)Patients under warfarin 3)Stable patients after standard theraphy for CTEPH has been completed. 4)>= 20 years old 5)Patient with a written informed consent
Key exclusion criteria	1)Patient who is scheduled for PEA and/or BPA. 2)Newly initiation of soluble guanylate cyclase stimulator 3)Recent induction of homeoxygen therapy 4)Contraindication for edoxaban 5)High risk patients of bleeding 6)Past history of alveolar hemorrhage 7)cCr<30mL/min 8)Patients who taking more than 2 antiplatelet drugs 9)pregnant/lactating woman
Target sample size	60

Research contact person
Name of lead principal investigator	Kazuhiko Nakayama
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Address	5-2,7-chome, Kusunoki, Chuo, Kobe, Hyogo, 650-0017, Japan
TEL	078-382-5846
Email	nakayama@med.kobe-u.ac.jp

Public contact
Name of contact person	Kazuhiko Nakayama
Organization	Department of Internal Medicine
Division name	Division of Cardiovascular Medicine
Address	5-2,7-chome, Kusunoki, Chuo, Kobe, Hyogo, 650-0017, Japan
TEL	078-382-5846
Homepage URL	http://www.med.kobe-u.ac.jp/im1/index.html
Email	nakayama@med.kobe-u.ac.jp

Sponsor
Institute	Division of Cardiovascular Medicine, Department of Internal Medicine Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Daiichi Sankyo Company, Limited
Organization
Division
Category of Funding Organization	Profit organization
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	神戸大学医学部附属病院 (兵庫県)

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 10 Month 31 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 02 Day
Last modified on	2016 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021437