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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033283
Receipt No. R000037948
Official scientific title of the study Safety and efficacy of 4 difference direct oral anticoagulants, dabigatran, rivaroxaban, apixaban and edoxaban in real-world clinical practice: a single center prospective all-comer registry
Date of disclosure of the study information 2018/07/04
Last modified on 2018/07/14

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Basic information
Official scientific title of the study Safety and efficacy of 4 difference direct oral anticoagulants, dabigatran, rivaroxaban, apixaban and edoxaban in real-world clinical practice: a single center prospective all-comer registry
Title of the study (Brief title) DIRECT registry
Region
Japan

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

Objectives
Narrative objectives1 The purpose of the present study is to evaluate the safety and effectiveness of 4 different direct oral anticoagulants in Japanese real-world clinical practice.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary safety end point was the occurrence of clinically significant bleeding [a composite of major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria and any minor bleeding].

The primary efficacy end point was the occurrence of a major adverse cardiovascular event (a composite of death from cardiovascular causes, myocardial infarction, or stroke).
Key secondary outcomes Secondary endpoints were each individual components of the primary safety and efficacy endpoints.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Non-valvular atrial fibrillation
Key exclusion criteria None
Target sample size 2000

Research contact person
Name of lead principal investigator Akio Hirata
Organization Osaka Police Hospital
Division name Department of Cardiology
Address 10-31, Kitayama, Tennoji, Osaka, Japan
TEL 0667716051
Email ohkohchan@gmail.com

Public contact
Name of contact person Yohei Sotomi
Organization Osaka Police Hospital
Division name Department of Cardiology
Address 10-31, Kitayama, Tennoji, Osaka, Japan
TEL 0667716051
Homepage URL
Email sotomiyohei@gmail.com

Sponsor
Institute Department of Cardiology, Osaka Police Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2018 Year 07 Month 04 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2011 Year 06 Month 01 Day
Anticipated trial start date
2011 Year 06 Month 01 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 The safety and efficacy of the four different direct oral anticoagulants in patients with non-valvular atrial fibrillation will be evaluated.

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2018 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037948

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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