UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019496 |
|---|---|
| Receipt number | 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 20:55:57 |
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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
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
dizumi@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
