UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011830 |
|---|---|
| Receipt number | 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 17:51:15 |
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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
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
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 | Yutaka |
| Middle name | |
| Last name | Hatori |
Organization
Hatori Clinic
Division name
Internal Medicine
Zip code
212-0085
Address
1-8-33 Kashimada Saiwai-ku Kawasaki-shi Kanagawa
TEL
044-522-0033
yutaka@hatori.or.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Hatori |
Organization
Hatori Clinic
Division name
Internal Medicine
Zip code
212-0085
Address
1-8-33 Kashimada Saiwai-ku Kawasaki-shi Kanagawa
TEL
044-522-0033
Homepage URL
http://ASSAF-K.umin.jp
yutaka@hatori.or.jp
Sponsor or person
Institute
ASSAF-K steering committee
Institute
Department
Personal name
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
Kanagawa Prefecture Medical Association
Address
3-1 Fujimi-cho Naka-ku Yokohama, Kanagawa
Tel
045-241-7000
k-ozawa@kanagawa.med.or.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
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
| 2013 | Year | 06 | Month | 30 | Day |
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013773
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
