UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the influence of physiological anti-coagulant factor, inflammation, and aging on the various anti-coagulation therapies
Title of the study (Brief title)	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	Minamino Tohru
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Cardiovascular Biology and Medicine
Address	1-754 Asahimachidori, Niigata, Japan
TEL	+81-25-227-2185
Email	tminamino@med.niigata-u.ac.jp

Public contact
Name of contact person	Daisuke Izumi
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Cardiovascular Biology and Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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