UMIN-CTR Clinical Trial

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

nonvalvularAtrial Fibrillation patients

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Associations of various clinical factors with selection of antithrombotic drugs

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name

Organization

Nippon Boehringer Ingelheim Co. Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2012

Year

12

Month

27

Day

URL releasing protocol

Publication of results

Published

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

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 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.

Registered date

2012

Year

12

Month

27

Day

Last modified on

2016

Year

08

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011313