UMIN-CTR Clinical Trial

Basic information
Public title	Elucidation of individual difference factors in the pharmacokinetics and clinical effects of anticoagulants edoxaban and enoxasaparin
Acronym	Elucidation of individual difference factors in the pharmacokinetics and clinical effects of anticoagulants edoxaban and enoxasaparin
Scientific Title	Elucidation of individual difference factors in the pharmacokinetics and clinical effects of anticoagulants edoxaban and enoxasaparin
Scientific Title:Acronym	Elucidation of individual difference factors in the pharmacokinetics and clinical effects of anticoagulants edoxaban and enoxasaparin
Region	Japan

Condition
Condition	Artificial knee replacement surgery
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Elucidation of individual differences in therapeutic effects and side effects of edoxaban and enoxaparin
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Efficacy (presence of thrombus by CT imaging)
Key secondary outcomes	Safety (with subcutaneous bleeding)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Edoxaban
Interventions/Control_2	Enoxaparin
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	undergoing knee replacement
Key exclusion criteria	Patients with a history of DVT and PTE. Patients with diseases with abnormal coagulability. Patient who can not obtain written informed consent. Patients contraindicated with edoxaban or enoxaparin. Patients taking warfarin.Other patients judged inappropriate by the attending physician.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kaneko,Hironori
Organization	Kitasato University, Kitasato Institute Hospital
Division name	Orthopedics
Zip code
Address	5-9-1 shirokane minato-ku tokyo
TEL	03-3444-6161
Email	hiroka@insti.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name shibata,soichi
Organization	Kitasato University, Kitasato Institute Hospital
Division name	Pharmacy
Zip code
Address	5-9-1 shirkane minato-ku tokyo
TEL	03-3444-6161
Homepage URL
Email	shibasoh@insti.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	北里大学北里研究所病院

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 04 Month 24 Day
Date of IRB	2015 Year 04 Month 24 Day
Anticipated trial start date	2015 Year 06 Month 04 Day
Last follow-up date	2018 Year 08 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 17 Day
Last modified on	2021 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038109