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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010477
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Neurology, Kansai Medical University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012248

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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