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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014420
Receipt No. R000016781
Scientific Title Real World Survay of Atrial Fibrillation Patients Treated with Warfarine and Non-vitamin K Antagonist Oral Anticoaglants: SAKURA AF REGISTRY
Date of disclosure of the study information 2014/09/18
Last modified on 2019/10/05

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Basic information
Public title Real World Survay of Atrial Fibrillation Patients Treated with Warfarine and Non-vitamin K Antagonist Oral Anticoaglants: SAKURA AF REGISTRY
Acronym Multicenter Registry Study of Atrial Fibrillation Patients
Scientific Title Real World Survay of Atrial Fibrillation Patients Treated with Warfarine and Non-vitamin K Antagonist Oral Anticoaglants: SAKURA AF REGISTRY
Scientific Title:Acronym Multicenter Registry Study of Atrial Fibrillation Patients
Region
Japan

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

Objectives
Narrative objectives1 1. to clarify the real-world use of anticoaglants in patients with atrial fibrillation.
2. to determine the outcome of safety and efficacy of warfarin and non-vitamin K antagonist oral anticoaglants in patients with atrial fibrillation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effictiveness: ischemic stroke or non-central nervous system systemic embolism
Safety: Major bleeding events
Key secondary outcomes Effectiveness: stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, acute myocardial infarction, unstable angina, cardiovascular death, deep vein thrombosis, pulmonary embolism chapter, transient ischemic attack
Safety: non-major bleeding events

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Atrial fibrillation patients aged 20 years or older attending clinic or hospital treated by warfarin or non-vitamin K oral anticoaglants
Key exclusion criteria 1) Patients with absolute contraindications to anticoaglants
2) Patients with severe liver disease, kidney disease, blood disorders, lung disease, etc.
3) Pregnant women, breastfeeding women, possibly pregnant women
4) Patient administrated with HIV protease inhibitor (ritonavir, atazanavir, indinavir, etc.)
5) Patients administered with azole antifungal agents (except fluconazole, itraconazole, voriconazole, ketoconazole, etc.)
6) Other, inappropriate patients judged by research doctor or research investigator
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Okumura
Organization Department of Medicine, Nihon University School of Medicine
Division name Division of Cardiology
Zip code
Address 30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo
TEL 03-3972-8111
Email yasuwo128@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kokubun Yukimi
Organization RPM Co.,Ltd.
Division name SAKURA AF registry secretariat
Zip code
Address 3-2-4 Nishishinjuku, Shinjuku-ku, Tokyo
TEL 03-5325-5821
Homepage URL http://www.med.nihon-u.ac.jp/department/cardio/info/sakura.html
Email sakura@rpmedical.co.jp

Sponsor
Institute Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Bayer Yakuhin Ltd.
Daiichi Sankyo Company Ltd.
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 18 Day

Related information
URL releasing protocol https://www.jstage.jst.go.jp/article/circj/82/10/82_CJ-18-0535/_article
Publication of results Partially published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/circj/82/10/82_CJ-18-0535/_article
Number of participants that the trial has enrolled
Results
3,237 patients were enrolled from 63 institutions in the Tokyo area being treated with any of 4 DOACs(n=1,676) or warfarin(n=1,561) (followed-up for a median of 39.3 months). There were no significant differences in rates of stroke, major bleeding, and all-cause mortality for DOAC vs. warfarin users. Under propensity score matching, the incidence of stroke and all-cause death remained equivalent, but the incidence of major bleeding was significantly lower among DOAC than warfarin users.
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 No longer recruiting
Date of protocol fixation
2012 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 01 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information Multicenter, prospective observational study

Management information
Registered date
2014 Year 06 Month 30 Day
Last modified on
2019 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016781


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