UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010477 |
|---|---|
| Receipt number | R000012248 |
| Scientific Title | Efficacy and safety of anticoagulant treatment using new alternative antithrombotic agents in acute cardioembolic stroke with nonvalvular atrial fibrillation. |
| Date of disclosure of the study information | 2013/04/22 |
| Last modified on | 2018/12/03 11:26:30 |
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Basic information
Public title
Efficacy and safety of anticoagulant treatment using new alternative antithrombotic agents in acute cardioembolic stroke with nonvalvular atrial fibrillation.
Acronym
Efficacy and safety of anticoagulant treatment using new alternative antithrombotic agents in acute cardioembolic stroke with nonvalvular atrial fibrillation.
Scientific Title
Efficacy and safety of anticoagulant treatment using new alternative antithrombotic agents in acute cardioembolic stroke with nonvalvular atrial fibrillation.
Scientific Title:Acronym
Efficacy and safety of anticoagulant treatment using new alternative antithrombotic agents in acute cardioembolic stroke with nonvalvular atrial fibrillation.
Region
| Japan |
Condition
Condition
cerebral infarction
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of anticoagulant treatment using new alternative antithrombotic agents in acute cardioembolic stroke with nonvalvular atrial fibrillation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
early recurrent stroke within 14 days, all embolism within 14 days except ischemic stroke, all strokes within 14 days, all hemorrhagic event within 14 days
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients within 48 hours after onset of cardioembolism with nonvalvular atrial fibrillation are treated with oral new alternative antithrombotic agents.
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 within 48 hours after onset of cardioembolism with nonvalvular atrial fibrillation
Key exclusion criteria
1)extensive cerebral infarction(more than one third of the middle cerebral artery territory)
2)severe dysphagia
3)hepatic function disorder (Child-Pugh B or C)
4)renal dysfunction (CCr<30ml/min)
5)anemia (Hb<10.0g/dl)
6)hemorrhagic event
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takenobu Kunieda |
Organization
Kansai Medical University
Division name
Department of Neurology
Zip code
Address
2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kansai Medical University
Division name
Department of Neurology
Zip code
Address
2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Neurology, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
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
Terminated
Date of protocol fixation
| 2013 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 12 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 12 | Day |
Last modified on
| 2018 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012248
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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