UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036769
Receipt No. R000041896
Scientific Title Efficacy and Safety Evaluation According to Plasma Concentration Measurement on Direct Oral Anticoagulation Using Factor-Xa Inhibitors for Non-valvular Atrial Fibrillation on Multicenter Study
Date of disclosure of the study information 2019/05/17
Last modified on 2019/05/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy and Safety Evaluation According to Plasma Concentration Measurement on Direct Oral Anticoagulation Using Factor-Xa Inhibitors for Non-valvular Atrial Fibrillation on Multicenter Study
Acronym SETtu DOAC Registry(SET DOAC Registry)
Scientific Title Efficacy and Safety Evaluation According to Plasma Concentration Measurement on Direct Oral Anticoagulation Using Factor-Xa Inhibitors for Non-valvular Atrial Fibrillation on Multicenter Study
Scientific Title:Acronym SETtu DOAC Registry(SET DOAC Registry)
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of the efficacy and safety of medication management by drug blood concentration monitoring
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Bleeding and thrombosis events and blood DOAC concentration from the start of medication to 12 months
Key secondary outcomes Measurement values of molecular markers and coagulation tests from the start of medication to 12 months

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Non-valvular atrial fibrillation
Key exclusion criteria Patients judged by the attending physician as inappropriate for this study
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name Michihiro
Middle name
Last name Suwa
Organization Hokusetsu General Hospital
Division name Clinical laboratory division
Zip code 569-0852
Address 6-24 Kitayanagawa-cho Takatsuki-city Osaka-fu
TEL 072-696-2121
Email suwa-mic@hokusetsu-hp.jp

Public contact
Name of contact person
1st name Michihiro
Middle name
Last name Suwa
Organization Hokusetsu General Hospital
Division name Clinical laboratory division
Zip code 569-0852
Address 6-24 Kitayanagawa-cho Takatsuki-city Osaka-fu
TEL 072-696-2121
Homepage URL
Email suwa-mic@hokusetsu-hp.jp

Sponsor
Institute Hokusetsu General Hospital
Clinical laboratory division
Institute
Department

Funding Source
Organization Sysmex corporation
Hemostasis Business Development
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

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

IRB Contact (For public release)
Organization Hokusetsu General Hospital
Address 6-24 Kitayanagawa-cho Takatsuki-city Osaka-fu
Tel 072-696-2121
Email suwa-mic@hokusetsu-hp.jp

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 05 Month 17 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 Open public recruiting
Date of protocol fixation
2018 Year 08 Month 01 Day
Date of IRB
2018 Year 08 Month 09 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluation of cut-off level in blood drug concentration
cut-off level
Evaluation of time course in blood drug concentration
Evaluation of coagulation related markers (Fibrin monomer complex, CWA parameters)

Management information
Registered date
2019 Year 05 Month 16 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041896

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.