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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011830
Receipt No. R000013773
Scientific Title A Study of Safety and efficacy of anticoagulant therapy in the treatment of Atrial Fibrillation in KANAGAWA
Date of disclosure of the study information 2013/09/21
Last modified on 2019/04/27

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Basic information
Public title A Study of Safety and efficacy of anticoagulant therapy in the treatment of Atrial Fibrillation in KANAGAWA
Acronym ASSAF-K
Scientific Title A Study of Safety and efficacy of anticoagulant therapy in the treatment of Atrial Fibrillation in KANAGAWA
Scientific Title:Acronym ASSAF-K
Region
Japan

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

Objectives
Narrative objectives1 To clarify real-world pharmacological treatments for the patients with atrial fibrillation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1. clinical profiles of the patients
2. clinical status of treatments
3. outcome
3-1 survive or died and its cause (cardiac or cerebro-vascular, others)
3-2 cerebro-vascular events (cerebral infarction, intra-cranial bleeding, sequela: symptomatic or transient)
3-3 bleeding (Major or others)
Major bleeding defined by the criteria of International Society on Thrombosis and Haemostasis.
Key secondary outcomes 1. Relationship between efficacy/safety and treatments
2. comparison between pharmacological treatments regarding outcome

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 Patients with any type of atrial fibrillation
Key exclusion criteria Inappropriate patients considered by attending physicians
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hatori
Organization Hatori Clinic
Division name Internal Medicine
Zip code
Address 1-8-33 Kashimada Saiwai-ku Kawasaki-shi Kanagawa
TEL 044-522-0033
Email yutaka@hatori.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hatori
Organization Hatori Clinic
Division name Internal Medicine
Zip code
Address 1-8-33 Kashimada Saiwai-ku Kawasaki-shi Kanagawa
TEL 044-522-0033
Homepage URL http://ASSAF-K.umin.jp
Email yutaka@hatori.or.jp

Sponsor
Institute ASSAF-K steering committee
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 Kawasaki Physicians Association
Organization
Division
Category of Funding Organization Local Government
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 川崎市内科医会、神奈川県内科医師会等より公募

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 21 Day

Related information
URL releasing protocol http://ASSAF-K.umin.jp
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2013 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 11 Day
Last follow-up date
2017 Year 01 Month 01 Day
Date of closure to data entry
2019 Year 03 Month 30 Day
Date trial data considered complete
2019 Year 04 Month 27 Day
Date analysis concluded
2020 Year 07 Month 31 Day

Other
Other related information Patient characteristics
Medical history
History of medicatio
Clinical profiles at the time of registration
Medications during the study
Aims for medications
Outcome

Management information
Registered date
2013 Year 09 Month 21 Day
Last modified on
2019 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013773


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