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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009644
Receipt No. R000011313
Scientific Title Japanese study on current Anticoagulation therapies for Patients with nonvalvular Atrial Fibrillation.
Date of disclosure of the study information 2012/12/27
Last modified on 2016/08/18

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Basic information
Public title Japanese study on current Anticoagulation therapies for Patients with nonvalvular Atrial Fibrillation.
Acronym Japanese study on current Anticoagulation therapies for Patients with nonvalvular Atrial Fibrillation. (JAPAF)
Scientific Title Japanese study on current Anticoagulation therapies for Patients with nonvalvular Atrial Fibrillation.
Scientific Title:Acronym Japanese study on current Anticoagulation therapies for Patients with nonvalvular Atrial Fibrillation. (JAPAF)
Region
Japan

Condition
Condition nonvalvularAtrial Fibrillation patients
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives are:-To investigate current anticoagulation therapies, performed to prevent patients with nonvalvular atrial fibrillation from ischemic stroke and systemic embolism.-To clarify factors which can have an influence on a doctor's prescription.
Basic objectives2 Others
Basic objectives -Others -
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Associations of various clinical factors with selection of antithrombotic drugs
Key secondary outcomes

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 Patients with nonvalvular atrial fibrillation who have been treated with antithrombotic medicines (other than dabigatran etexilate) in order to prevent from ischemic stroke and systemic embolism. The post-marketing surveillance for dabigatran etexilate is separately conducted by its manufacturer.We will apply the result of the surveillance to our study, therefore patients on dabigatran etexilate treatment won't be included.
Key exclusion criteria There are no exclusion criteria for this study.
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Koizumi
Organization Kyoto University Graduate School of Medicine
Division name Department of Health and Environmental Sciences
Zip code
Address Konoe-cho Yoshida Sakyo-ku,Kyoto 606-8501,JAPAN
TEL 075-753-4456
Email koizumi.akio.5v@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Harada
Organization Kyoto University Graduate School of Medicine
Division name Department of Health and Environmental Sciences
Zip code
Address Konoe-cho Yoshida Sakyo-ku,Kyoto 606-8501,JAPAN
TEL 075-753-4456
Homepage URL
Email AFAntithrombotic@umin.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nippon Boehringer Ingelheim Co. Ltd.
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
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 試験実施施設数 305施設
セッティング 病院・医院
試験実施都道府県 北海道/Hokkaido青森県/Aomori-ken岩手県/Iwate-ken秋田県/Akita-ken山形県/Yamagata-ken宮城県/Miyagi-ken福島県/Fukushima-ken新潟県/Niigata-ken群馬県/Gunma-ken茨木県/Ibaraki-ken埼玉県/Saitama-ken栃木県/Tochigi-ken千葉県/Chiba-ken東京都/Toukyou-to神奈川県/Kanagawa-ken長野県/Nagano-ken山梨県/Yamanashi-ken静岡県/Shizuoka-ken富山県/Toyama-ken石川県/Ishikawa-ken福井県Fukui-ken岐阜県/Gifu-ken愛知県/Aichi-ken三重県/Mie-ken滋賀県/Shiga-ken京都府/Kyouto-hu大阪府/Oosaka-fu和歌山県/Wakayama-ken兵庫県/Hyogo-ken鳥取県/Tottori-ken島根県/Shimane-ken広島県/Hiroshima-ken山口県/Yamaguchi-ken岡山県/Okayama-ken福岡県/Fukuoka-ken佐賀県/Saga-ken宮崎県/Miyazaki-ken鹿児島県/Kagoshima-ken大分県/Ooita-ken熊本県/Kumamoto-ken沖縄県/Okinawa-ken

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://dx.doi.org/10.1016/j.joa.2016.06.006
Number of participants that the trial has enrolled
Results
 Patients with NVAF taking antithrombotics other than DTIs were enrolled in this cross-sectional study. Patient demographics and medication history were collected, and patients were classified as taking antiplatelet monotherapy (AP), anticoagulant monotherapy (AC), or combination therapy (AP+AC). OAC (AC and AP+AC) users were also stratified as naive (N; initiated within 6 months), switcher (S; switched within 6 months), or prevalent (P; continued over 6 months).
A total of 3,053 patients (AP, 216; AC, 2,381; AP+AC, 456) from 268 sites were enrolled from 2012 to 2013. Significant differences were observed in CHADS2 (AP/AC/AP+AC: 2.0/2.1/2.7, P<0.0001), angina complications (20.1/8.6/32.1, P<0.0001), myocardial infarction (5.1/2.8/18.1, P<0.0001), prothrombin time-international normalized ratio (PT-INR) (-/2.00/1.94, P=0.0350) and others. There were 2,831 OAC users (N, 328; S, 213; P, 2,290). Significant differences were observed in history of bleeding (N/S/P: 2.4/9.4/4.5, P<0.001), PT-INR (1.83/2.01/2.00, P<0.0001) and others.
In conclusion, patients taking an AP+AC had higher CHADS2 than those taking an AP or AC alone. Additionally, combination therapy (AP+AC) was preferred in patients with cardiovascular complications. ACs continued to be prescribed in patients with bleeding episodes, while APs were changed. Changes in AC regimens were not influenced by CHADS2 or complications, except history of bleeding.
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 Completed
Date of protocol fixation
2011 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
2014 Year 01 Month 31 Day
Date trial data considered complete
2014 Year 02 Month 28 Day
Date analysis concluded
2014 Year 07 Month 31 Day

Other
Other related information Patients that meet the eligibility criteria, to be investigated for the following items using electronic questionnaire (i-CRF Case Report Form).

1) Patient background
(1) Sex
(2) Date of Birth
(3) Height, weight
(4) Presence or absence of predisposition hypersensitivity , diagnosis, causative agent
(5) Smoking, drinking habit

2) Atrial fibrillation
(1) Date of onset
(2) Asymptomatic, symptomatic
(3) disease type, Paroxysmal, persistence, unknown
(4) Presence or absence of treatment and surgery
Investigate the presence or absence of treatment and following surgery, the most recent date for implementation.
Electrical defibrillation, cardioversion drugs, ablation, pacemakers, left atrial appendage occlusion technique,
Excision of the left atrial appendage

3) Patient background, past history, complications
(1) Presence or absence of complications, medical history
(2) Detailed medical history, complications

4) History of bleeding
(1) Presence or absence of bleeding that requires medical intervention in the past
(2) Bleeding site Intracranial, spinal cord intrathecal, retroperitoneal, intra-articular, pericardial space, intramuscular, gastrointestinal tract, urinary, genital, and other
(3) Antithrombotic drug usage at the time of expression of bleeding events
(4) Bleeding status Presence or absence of a decrease in hemoglobin, the presence or absence of transfusion of 5 units or more

5) Antithrombotics
Presence or absence of the use of anticoagulants, antiplatelet drugs at the time of the survey, dosage, administration start date, the presence or absence of prior treatment, drug , and duration of administration.

6) Drug treatment other than antithrombotics
Investigate the drug that was used in addition to anticoagulants, antiplatelet drugs at the time of the survey.

7) Combination therapy
- Investigate the combination therapy, other than electrical cardioversion, concomitant medication, ablation.

Management information
Registered date
2012 Year 12 Month 27 Day
Last modified on
2016 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011313

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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