UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of anticoagulant treatment using new alternative antithrombotic agents in acute cardioembolic stroke with nonvalvular atrial fibrillation.
Title of the study (Brief title)	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	Takenobu Kunieda
Organization	Kansai Medical University
Division name	Department of Neurology
Address	2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan
TEL
Email

Public contact
Name of contact person
Organization	Kansai Medical University
Division name	Department of Neurology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 03 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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