UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014420 |
|---|---|
| Receipt number | 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 | 2022/05/30 08:58:34 |
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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
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
| 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 | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Department of Medicine, Nihon University School of Medicine
Division name
Division of Cardiology
Zip code
176-8310
Address
30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo
TEL
0339728111
okumura.yasuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukimi |
| Middle name | |
| Last name | Kokubun |
Organization
RPM Co.,Ltd.
Division name
SAKURA AF registry secretariat
Zip code
160-0023
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
sakura@rpmedical.co.jp
Sponsor or person
Institute
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Institute
Department
Personal name
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
Nihon University Itabashi Hospital Clinical Research Center
Address
30-1 Oyaguchi-Kami Itabashi-Ku
Tel
03-3972-8111(8476)
komoda.nozomi@nihon-u.ac.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
| 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
3268
Results
3,237 patients from 63 institutions in the Tokyo area being treated with any of 4 DOACs (n=1,676) or warfarin (n=1,561) were followed-up (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
| 2019 | Year | 10 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 09 | Month | 25 | Day |
Baseline Characteristics
We conducted our first analysis of the registry data, and although we found equivalent mean age between the DOAC and warfarin users (71.8+/-9.5 vs.72.3+/-9.4 years, p=0.2117), we found a slightly lower risk of stroke (CHADS2 score of 0 or 1 [46.9% vs. 39.4%, p<0.0001]) and significantly better creatinine clearance in DOAC users (70.4+/-27 vs. 65.6+/-25.7 mL/min, p<0.0001). Importantly, we documented under-dosing in 32% of warfarin users and inappropriate-low-dosing in 19.7-27.6% of DOAC users.
Participant flow
The SAKURA AF registry enrolled 3267 AF patients treated by warfarin or NOACs from 63 institutions. The patient's registration was finished on December 31, 2015.
the follow-up was ended in December 31, 2018.
Adverse events
Stroke/TIA: DOAC 1.2 vs. warfarin 1.8%/year
Major bleeding: DOAC　0.5 vs. warfarin 1.2%/year
Death: DOAC 2.1 vs. warfarin 1.7%/year
Outcome measures
Primary effectiveness endpoint: stroke/TIA
Primary safety endpoint: Major bleeding,
Secondary endpoint: death, CV events
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 01 | Day |
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
| 2022 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016781
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| Registered date | File name |
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