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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019496
Receipt No. R000022331
Scientific Title Evaluation of the influence of physiological anti-coagulant factor, inflammation, and aging on the various anti-coagulation therapies
Date of disclosure of the study information 2015/11/01
Last modified on 2019/03/06

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Basic information
Public title Evaluation of the influence of physiological anti-coagulant factor, inflammation, and aging on the various anti-coagulation therapies
Acronym Evaluation of the influence of physiological anti-coagulant factor, inflammation, and aging on the various anti-coagulation therapies
Scientific Title Evaluation of the influence of physiological anti-coagulant factor, inflammation, and aging on the various anti-coagulation therapies
Scientific Title:Acronym Evaluation of the influence of physiological anti-coagulant factor, inflammation, and aging on the various anti-coagulation therapies
Region
Japan

Condition
Condition Atrial fibrillation, paroxysmal supraventricular tachycardia, ventricular arrhythmias, and patients with cardiac Implantable electronic device (CIED)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the influence of physiological anti-coagulant factor, inflammation, and aging on the various anti-coagulation therapies
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Major bleeding complication, ischemic stroke, TIA, systemic embolism
Key secondary outcomes

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 Adult patients with arrhythmias who fit the indication of radiofrequency catheter ablation for arrhythmias and/or CIED therapy
Key exclusion criteria The patient without prior written consent, and the patient who receives urgent treatment.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minamino Tohru
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Cardiovascular Biology and Medicine
Zip code
Address 1-754 Asahimachidori, Niigata, Japan
TEL +81-25-227-2185
Email tminamino@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Izumi
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Cardiovascular Biology and Medicine
Zip code
Address 1-754 Asahimachidori, Niigata, Japan
TEL +81-25-227-2185
Homepage URL
Email dizumi@med.niigata-u.ac.jp

Sponsor
Institute Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2015 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results In contrast to warfarin treatment, DOAC treatment preserves thrombin generation in response to vascular injury and maintains protein C, protein S, and factor VII levels, which could partly explain the lower risk of hemorrhagic complications and thromboembolic events in patients using these anticoagulants. Among DOACs, direct thrombin inhibitors and factor Xa inhibitors may act differently on the coagulation system and this could lead to distinct clinical outcomes.
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 Completed
Date of protocol fixation
2014 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 01 Day
Date of closure to data entry
2019 Year 03 Month 01 Day
Date trial data considered complete
2019 Year 03 Month 01 Day
Date analysis concluded
2019 Year 03 Month 01 Day

Other
Other related information [Study design]
Prospective, single center, observational study.

[Target population]
Patients who are admitted to our institution between Apr 2014 and Mar 2018 and matched the inclusion criteria of this study.

Management information
Registered date
2015 Year 10 Month 26 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022331

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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